S E N D L L C

FDA Filings

This page includes the latest FDA filings for S E N D L L C. 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
DIBAR LABS Hand Sanitizer S.E.N.D. LLC	Otc Medication	2021-02-02
NDC 81500-010 S.E.N.D. LLC	DIBAR LABS Hand Sanitizer	2021-01-11

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• SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SRS MEDICAL76 Treble Cove Road, #3north Billerica, MA 01862 PMA NumberP060010 Supplement NumberS013 Date Received06/22/2020 Decision Date10/07/2022 Product Code NZC  Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02643849 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS027 Date Received08/31/2022 Decision Date09/29/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SYNCARDIA SYSTEMS, LLC1992 E. Silverlake Rd.tucson, AZ 85713 PMA NumberP030011 Supplement NumberS082 Date Received08/23/2022 Decision Date09/22/2022 Product Code LOZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS026 Date Received08/23/2022 Decision Date09/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS025 Date Received08/16/2022 Decision Date09/13/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS007 Date Received06/03/2022 Decision Date09/01/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS024 Date Received08/05/2022 Decision Date09/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS079 Date Received08/01/2022 Decision Date08/31/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS116 Date Received06/17/2022 Decision Date08/19/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS011 Date Received05/11/2022 Decision Date08/09/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS023 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS049 Date Received07/14/2022 Decision Date08/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SUNEVA MEDICAL, INC.5879 Pacific Center Blvd.san Diego, CA 92121 PMA NumberP020012 Supplement NumberS041 Date Received07/08/2022 Decision Date08/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS010 Date Received05/09/2022 Decision Date08/03/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS009 Date Received04/29/2022 Decision Date07/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS048 Date Received06/22/2022 Decision Date07/22/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS037 Date Received06/17/2022 Decision Date07/20/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS035 Date Received04/08/2022 Decision Date07/05/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS048 Date Received06/06/2022 Decision Date07/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS011 Date Received06/09/2022 Decision Date07/01/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS021 Date Received06/13/2022 Decision Date06/24/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP150030 Supplement NumberS022 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.1450 Brooks Roadmemphis, TN 38116 PMA NumberP030022 Supplement NumberS047 Date Received05/23/2022 Decision Date06/21/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Seno Medical Instruments, Inc.8023 Vantage Drive, Suite 1000san Antonio, TX 78230 PMA NumberP200003 Supplement NumberS001 Date Received11/01/2021 Decision Date06/17/2022 Product Code QNK  Advisory Committee Radiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS008 Date Received04/27/2022 Decision Date05/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SMITH&NEPHEW ORTHOPAEDICS7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS021 Date Received04/29/2022 Decision Date05/17/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS006 Date Received04/12/2022 Decision Date05/12/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS115 Date Received02/23/2022 Decision Date05/05/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• STAAR Surgical Company1911 Walker Ave.monrovia, CA 91016 PMA NumberP030016 Supplement NumberS043 Date Received04/04/2022 Decision Date05/04/2022 Product Code MTA  Advisory Committee Ophthalmic Clinical TrialsNCT04283149 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS020 Date Received04/06/2022 Decision Date05/03/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SILK ROAD MEDICAL, INC735 North Pastoria Avesunnyvale, CA 94085 PMA NumberP140026 Supplement NumberS019 Date Received04/22/2022 Decision Date05/03/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• St. Jude Medicalone St. Jude Medical Drivest. Paul, MN 55117 PMA NumberP130026 Supplement NumberS078 Date Received01/27/2022 Decision Date04/27/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS004 Date Received03/21/2022 Decision Date04/20/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW  Advisory Committee Radiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS062 Date Received03/14/2022 Decision Date04/11/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Svelte Medical Systems, Inc.675 Central Avenue, Suite 2new Providence, NJ 07974 PMA NumberP210014 Supplement NumberS001 Date Received01/12/2022 Decision Date04/08/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS002 Date Received03/07/2022 Decision Date04/06/2022 Product Code LGW  Advisory Committee Neurology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS010 Date Received03/08/2022 Decision Date04/05/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Smith & Nephew, Inc.7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP150030 Supplement NumberS019 Date Received03/07/2022 Decision Date04/01/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS047 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS061 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591-5097 PMA NumberP200017 Supplement NumberS002 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP040004 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP030040 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS511 Benedict Avenuetarrytown, NY 10591 PMA NumberP090024 Supplement NumberS011 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP990055 Supplement NumberS024 Date Received03/22/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS CORP.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP110041 Supplement NumberS013 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS006 Date Received12/22/2021 Decision Date03/23/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• St. Jude Medical387 Technology Circle Nwsuite 500atlanta, GA 30313 PMA NumberP100045 Supplement NumberS060 Date Received02/02/2022 Decision Date03/04/2022 Product Code MOM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SIENTRA, INC6769 Hollister Avenuesuite 201santa Barbara, CA 93117 PMA NumberP070004 Supplement NumberS034 Date Received01/31/2022 Decision Date03/02/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Date Received01/22/2019 Decision Date02/28/2022 Product Code LGW  Advisory Committee Neurology Clinical TrialsNCT02924129 Expedited Review Granted? No
• SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS114 Date Received02/14/2022 Decision Date02/24/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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