B L I D B P

FDA Filings

This page includes the latest FDA filings for B L I D B P. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9615704
• FEI Number: 3004729462
• Name: Jean Francois Rey
• Owner & Operator: B.L.I./D.B.P
• Contact Address: 74 route des Camoins --; MARSEILLE FR-NOTA 13011 FR
• Official Correspondent:
  • JEAN-FRANCOIS - REY
  • 33-491-296230-x
• US Agent:
  • Jean Francois Rey
  • JFREY Eyewear USA
  • 877 8891429
  • caroline@jfreyusa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1064 Whitledge Place ; Harrisburg, OR 97446 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006295263
• FEI Number: 3006295263
• Name: J.F. REY EYEWEAR USA, INC.
• Owner & Operator: B.L.I./D.B.P
• Contact Address: 74 route des Camoins --; MARSEILLE FR-NOTA 13011 FR
• Official Correspondent:
  • JEAN-FRANCOIS - REY
  • 33-491-296230-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1064 Whitledge Place ; Harrisburg, OR 97446 US

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
HQZ Jean Francois Rey [B.L.I./D.B.P]	JEAN-FRANCOIS REY	1998-04-13
HQY Jean Francois Rey [B.L.I./D.B.P]	JEAN-FRANCOIS REY	1998-04-13

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• 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
• 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
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• 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 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
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS118 Date Received11/30/2022 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS170 Date Received11/30/2022 Decision Date01/16/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS143 Date Received11/15/2022 Decision Date01/12/2023 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS169 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS100 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
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• 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 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 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
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• Baxter Healthcare Corporationone Baxter Parkwaydeerfield, IL 60015 PMA NumberP950034 Supplement NumberS055 Date Received11/23/2022 Decision Date12/22/2022 Product Code MCN  Advisory Committee General & Plastic Surgery 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.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
• 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
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• 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 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
• 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 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 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
• 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
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS168 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS116 Date Received11/10/2022 Decision Date12/07/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BOSTON SCIENTIFIC 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
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS099 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS241 Date Received11/10/2022 Decision Date12/07/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS142 Date Received11/10/2022 Decision Date12/07/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• 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 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
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS240 Date Received09/26/2022 Decision Date12/02/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material 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 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 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 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.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
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• 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 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.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
• BAXTER HEALTHCARE CORP.32650 N Wilson Rdround Lake, IL 60073 PMA NumberP990009 Supplement NumberS071 Date Received10/26/2022 Decision Date11/22/2022 Product Code PMX  Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename 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.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 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
• BECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ  Advisory Committee Microbiology 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 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
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS141 Date Received10/18/2022 Decision Date11/16/2022 Product Code NKE  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 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 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.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 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 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 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 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.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.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
• BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS024 Date Received10/18/2022 Decision Date11/08/2022 Product Code MDP  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 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 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 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.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.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 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 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
• 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 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 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
• 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 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 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
• 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.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 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
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS103 Date Received09/29/2022 Decision Date10/25/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS115 Date Received09/22/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS140 Date Received09/22/2022 Decision Date10/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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