Bo I N T

FDA Filings

This page includes the latest FDA filings for Bo I N T. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
NDC 80528-378 BO INTERNATIONAL	Hand Sanitizer	2020-09-15
Hand Sanitizer BO INTERNATIONAL	Otc Medication	2020-09-15

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• Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS204 Date Received01/06/2023 Decision Date02/02/2023 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bolton Medical Inc.799 International Pkwysunrise, FL 33325 PMA NumberP190015 Supplement NumberS010 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS027 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS056 Date Received10/25/2022 Decision Date01/20/2023 Product Code NGV  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS134 Date Received01/10/2023 Decision Date01/18/2023 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910073 Supplement NumberS171 Date Received01/05/2023 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS356 Date Received12/08/2022 Decision Date01/06/2023 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS054 Date Received12/08/2022 Decision Date01/06/2023 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Neuromodulation25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP140004 Supplement NumberS029 Date Received12/08/2022 Decision Date01/06/2023 Product Code NQO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS359 Date Received12/28/2022 Decision Date01/04/2023 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS282 Date Received12/12/2022 Decision Date12/20/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS566 Date Received12/12/2022 Decision Date12/20/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS489 Date Received12/12/2022 Decision Date12/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS138 Date Received12/12/2022 Decision Date12/20/2022 Product Codes NVN LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS355 Date Received12/07/2022 Decision Date12/17/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS053 Date Received12/07/2022 Decision Date12/17/2022 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS137 Date Received12/09/2022 Decision Date12/15/2022 Product Codes NVN LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS281 Date Received12/07/2022 Decision Date12/14/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS565 Date Received12/07/2022 Decision Date12/14/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS177 Date Received12/07/2022 Decision Date12/14/2022 Product Codes NVY LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910077 Supplement NumberS190 Date Received11/16/2022 Decision Date12/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS488 Date Received12/07/2022 Decision Date12/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS136 Date Received12/07/2022 Decision Date12/14/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS280 Date Received10/26/2022 Decision Date12/12/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS132 Date Received12/02/2022 Decision Date12/07/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980037 Supplement NumberS089 Date Received11/09/2022 Decision Date12/07/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS176 Date Received11/10/2022 Decision Date12/07/2022 Product Codes LWS NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporation300 Boston Scientific Waymarlborough, MA 01752 PMA NumberP200029 Supplement NumberS004 Date Received11/02/2022 Decision Date12/02/2022 Product Code NAW  Advisory Committee Radiology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS206 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP930031 Supplement NumberS071 Date Received11/14/2022 Decision Date11/28/2022 Product Code MIR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.three Scimed Placemaple Grove, MN 55311-1566 PMA NumberP050019 Supplement NumberS036 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP090003 Supplement NumberS053 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP150003 Supplement NumberS089 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980033 Supplement NumberS061 Date Received11/14/2022 Decision Date11/28/2022 Product Code QKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC SCIMED, INC.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP940019 Supplement NumberS062 Date Received11/14/2022 Decision Date11/28/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS017 Date Received11/03/2022 Decision Date11/23/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP030017 Supplement NumberS352 Date Received11/14/2022 Decision Date11/22/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.25155 Rye Canyon Loopvalencia, CA 91355 PMA NumberP150031 Supplement NumberS051 Date Received11/14/2022 Decision Date11/22/2022 Product Code NHL  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP930031 Supplement NumberS070 Date Received10/27/2022 Decision Date11/22/2022 Product Code MIR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC SCIMED, INC.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP940019 Supplement NumberS061 Date Received10/27/2022 Decision Date11/22/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS072 Date Received08/26/2022 Decision Date11/21/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS131 Date Received11/15/2022 Decision Date11/17/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS073 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP920047 Supplement NumberS129 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP980003 Supplement NumberS094 Date Received10/17/2022 Decision Date11/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP060006 Supplement NumberS104 Date Received10/17/2022 Decision Date11/15/2022 Product Code NIN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS205 Date Received10/17/2022 Decision Date11/15/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130030 Supplement NumberS074 Date Received10/17/2022 Decision Date11/15/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS203 Date Received10/17/2022 Decision Date11/15/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS016 Date Received10/17/2022 Decision Date11/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC150 Baytech Drivesan Jose, CA 95134 PMA NumberP020025 Supplement NumberS137 Date Received10/17/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberN970012 Supplement NumberS194 Date Received11/01/2022 Decision Date11/14/2022 Product Code JCW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberP000053 Supplement NumberS128 Date Received11/01/2022 Decision Date11/14/2022 Product Code EZY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS015 Date Received10/06/2022 Decision Date11/10/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.ballybrit Industrial Estate, Ballybritgalway H91 Y PMA NumberP110035 Supplement NumberS068 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS051 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS055 Date Received10/18/2022 Decision Date11/07/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS129 Date Received10/25/2022 Decision Date11/07/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP140028 Supplement NumberS075 Date Received10/18/2022 Decision Date11/07/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS564 Date Received11/01/2022 Decision Date11/02/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP830060 Supplement NumberS088 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910073 Supplement NumberS170 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910077 Supplement NumberS189 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP930035 Supplement NumberS033 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960004 Supplement NumberS101 Date Received11/01/2022 Decision Date11/02/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960006 Supplement NumberS055 Date Received11/01/2022 Decision Date11/02/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS135 Date Received11/01/2022 Decision Date11/02/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS279 Date Received10/05/2022 Decision Date10/28/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS054 Date Received09/29/2022 Decision Date10/28/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS175 Date Received10/05/2022 Decision Date10/28/2022 Product Codes LWS NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS133 Date Received10/05/2022 Decision Date10/28/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS127 Date Received10/11/2022 Decision Date10/17/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS202 Date Received09/19/2022 Decision Date10/17/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS563 Date Received10/12/2022 Decision Date10/14/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP980033 Supplement NumberS060 Date Received09/14/2022 Decision Date10/14/2022 Product Code QKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP910073 Supplement NumberS169 Date Received10/07/2022 Decision Date10/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS487 Date Received10/12/2022 Decision Date10/14/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corporationthree Scimed Placemaple Grove, MN 55311-1566 PMA NumberP190019 Supplement NumberS014 Date Received09/15/2022 Decision Date10/12/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS126 Date Received09/19/2022 Decision Date09/30/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS276 Date Received09/20/2022 Decision Date09/27/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberP010012 Supplement NumberS557 Date Received09/20/2022 Decision Date09/27/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATION4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP110042 Supplement NumberS172 Date Received09/20/2022 Decision Date09/27/2022 Product Codes LWS NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960040 Supplement NumberS481 Date Received09/20/2022 Decision Date09/27/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS130 Date Received09/20/2022 Decision Date09/27/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP150005 Supplement NumberS071 Date Received08/22/2022 Decision Date09/21/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.150 Baytech Drivesan Jose, CA 95134 PMA NumberP920047 Supplement NumberS128 Date Received08/22/2022 Decision Date09/21/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC150 Baytech Drivesan Jose, CA 95134 PMA NumberP020025 Supplement NumberS136 Date Received08/22/2022 Decision Date09/21/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS125 Date Received09/06/2022 Decision Date09/15/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS200 Date Received04/11/2022 Decision Date09/02/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberN970012 Supplement NumberS192 Date Received08/19/2022 Decision Date09/01/2022 Product Code JCW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.100 Boston Scientific Waymarlborough, MA 01752 PMA NumberP000053 Supplement NumberS127 Date Received08/19/2022 Decision Date09/01/2022 Product Code EZY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP110010 Supplement NumberS204 Date Received08/09/2022 Decision Date09/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS050 Date Received08/08/2022 Decision Date08/29/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311-1566 PMA NumberP140028 Supplement NumberS074 Date Received08/08/2022 Decision Date08/29/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC CORPORATIONone Scimed Placemaple Grove, MN 55311 PMA NumberP090003 Supplement NumberS052 Date Received08/19/2022 Decision Date08/25/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS026 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bolton Medical, Inc.799 International Parkwaysunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS051 Date Received07/19/2022 Decision Date07/29/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP960004 Supplement NumberS100 Date Received07/26/2022 Decision Date07/28/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Boston Scientific Corp.4100 Hamline Ave Northst. Paul, MN 55112 PMA NumberN970003 Supplement NumberS274 Date Received07/21/2022 Decision Date07/27/2022 Product Code LWP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOBBI BROWN PROFESSIONAL COSMETICS INC
• Bobbie Weiner Enterprises, L.l.c.
• Bobby Dodd Institute
• Body Action Products, Inc
• Body Blue 2006 Incorporated
• Body Wisdom Center for Healing
• Boehringer Ingelheim Animal Health USA Inc
• BODY FRIEND CO., LTD
• BOEHRINGER LABORATORIES, LLC
• BOEKEL INDUSTRIES, INC.
• Bone Medical Technology(Shenzhen)Co., Ltd
• Bordier affinity products S.A.
• BOSS INSTRUMENTS, LTD., INC.
• BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020062210347	Nhava Sheva,India -> Los Angeles, California	CLAY MASK WITH KASTURI MANJA	18 CTN
202005202187	Mundra,India -> Port Everglades, Florida	MANGO BUTTER, WHITE BEESWAX, YELLOW BEESWAX	1127 CTN
2020042749257	Mundra,India -> Miami, Florida	MANGO BUTTER, WHITE BEESWAX, YELLOW BEESWAX	1127 CTN
2020012740103	Valencia,Spain -> Miami, Florida	ORGANIC WHITE AND YELLOW BEESWAX AND MANGO BUTTER	1080 PKG
2019091221882	Nhava Sheva,India -> Long Beach, California	I.C.DIESEL ENGINE SPARE	125 CTN
2019090934485	Nhava Sheva,India -> Long Beach, California	I.C.DIESEL ENGINE SPARE	125 CTN
201908204695	Valencia,Spain -> Miami, Florida	ORGANIC WHITE, YELLOW BEES WAX PELLETS, ORGAN .	1350 PKG
201908194912	Valencia,Spain -> Miami, Florida	ORGANIC WHITE, YELLOW BEES WAX PELLETS, ORGAN .	1350 PKG