C O S M E D S R L

FDA Filings

This page includes the latest FDA filings for C O S M E D S R L. 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
GUDID 18052400180539 C O S M E D SRL	COSMED	2020-02-21
GUDID 18052400180522 C O S M E D SRL	COSMED	2020-02-21
GUDID 18052400180485 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180379 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180362 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180355 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180287 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180263 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180249 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180225 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180201 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180188 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180171 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180164 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180157 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180126 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180096 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180072 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180065 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180058 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180041 C O S M E D SRL	COSMED	2018-07-06
GUDID 18052400180034 C O S M E D SRL	COSMED	2018-07-06

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• C.R. Bard, Inc1625 W. 3rd Streettempe, AZ 85528 PMA NumberP170042 Supplement NumberS012 Date Received01/06/2023 Decision Date02/02/2023 Product Code PFV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS008 Date Received12/23/2022 Decision Date01/20/2023 Product Code DSR  Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS153 Date Received12/21/2022 Decision Date01/19/2023 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS028 Date Received12/21/2022 Decision Date01/19/2023 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Channel Medsystems, Inc.5858 Horton Street, Suite 200emeryville, CA 94608 PMA NumberP180032 Supplement NumberS011 Date Received12/21/2022 Decision Date01/17/2023 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS015 Date Received12/19/2022 Decision Date01/13/2023 Product Code QIT  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS065 Date Received12/16/2022 Decision Date01/12/2023 Product Code FHW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS013 Date Received12/14/2022 Decision Date01/12/2023 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cirtec Medical Corporation9200 Xylon Avenue Nbrooklyn Park, MN 55445 PMA NumberP170001 Date Received01/17/2017 Decision Date01/11/2023 Product Code EZW  Advisory Committee Gastroenterology/Urology Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS014 Date Received12/16/2022 Decision Date01/10/2023 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS015 Date Received12/09/2022 Decision Date01/05/2023 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec, Inc.5160 Hacienda Drivedublin, CA 94568 PMA NumberP150040 Supplement NumberS011 Date Received11/22/2022 Decision Date12/21/2022 Product Code OTL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS152 Date Received11/29/2022 Decision Date12/21/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS023 Date Received09/28/2022 Decision Date12/20/2022 Product Codes NIO NIN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS048 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS046 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS216 Date Received11/21/2022 Decision Date12/15/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS027 Date Received11/14/2022 Decision Date12/12/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS012 Date Received09/30/2022 Decision Date12/07/2022 Product Code QIT  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS022 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS151 Date Received11/09/2022 Decision Date12/07/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS047 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS045 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS215 Date Received11/14/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS214 Date Received09/07/2022 Decision Date12/06/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS051 Date Received09/07/2022 Decision Date12/06/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS063 Date Received11/02/2022 Decision Date12/01/2022 Product Code FHW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP150011 Supplement NumberS026 Date Received10/24/2022 Decision Date11/21/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS150 Date Received10/25/2022 Decision Date11/21/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CERAPEDICS, LLC11025 Dover Streetsuite 1600westminster, CO 80021 PMA NumberP140019 Supplement NumberS007 Date Received10/19/2022 Decision Date11/15/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CARDIVA MEDICAL, INC.2900 Lakeside Drivesuite 160santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas400 Inverness Parkway,suite 400englewood, CO 80112 PMA NumberP840024 Supplement NumberS094 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas13059 E Peakview Avecentennial, CO 80111 PMA NumberP890027 Supplement NumberS062 Date Received04/26/2022 Decision Date10/31/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS047 Date Received04/26/2022 Decision Date10/31/2022 Product Code MHE  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS093 Date Received09/29/2022 Decision Date10/27/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CARBON MEDICAL TECHNOLOGIES, INC.1290 Hammond Rd.st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS149 Date Received09/30/2022 Decision Date10/26/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS011 Date Received08/23/2022 Decision Date09/22/2022 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS011 Date Received08/17/2022 Decision Date09/16/2022 Product Code FAF  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS010 Date Received08/17/2022 Decision Date09/15/2022 Product Code QIT  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS062 Date Received07/27/2022 Decision Date08/24/2022 Product Code FHW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS010 Date Received07/27/2022 Decision Date08/24/2022 Product Code FAF  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS148 Date Received07/21/2022 Decision Date08/18/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS213 Date Received07/11/2022 Decision Date08/09/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS147 Date Received07/11/2022 Decision Date08/08/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP130011 Supplement NumberS011 Date Received06/29/2022 Decision Date07/28/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP150011 Supplement NumberS025 Date Received06/29/2022 Decision Date07/28/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS146 Date Received04/27/2022 Decision Date07/25/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• CERAMTEC GMBHceramtec-platz 1-973207plochingen 73207 PMA NumberP010001 Supplement NumberS025 Date Received06/21/2022 Decision Date07/20/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS007 Date Received05/31/2022 Decision Date06/27/2022 Product Code DSR  Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS092 Date Received06/02/2022 Decision Date06/27/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec, Inc.5160 Hacienda Drivedublin, CA 94568 PMA NumberP150040 Supplement NumberS010 Date Received05/23/2022 Decision Date06/17/2022 Product Code OTL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ConMed Corporation525 French Roadutica, NY 13502 PMA NumberP200004 Supplement NumberS001 Date Received05/19/2022 Decision Date06/16/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS006 Date Received05/20/2022 Decision Date06/14/2022 Product Code DSR  Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Channel Medsystems, Inc.5858 Horton Street, Suite 200emeryville, CA 94608 PMA NumberP180032 Supplement NumberS010 Date Received05/02/2022 Decision Date05/31/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS014 Date Received04/26/2022 Decision Date05/13/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP050031 Supplement NumberS009 Date Received04/15/2022 Decision Date05/10/2022 Product Codes NUU MWL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP870024 Supplement NumberS062 Date Received04/15/2022 Decision Date05/10/2022 Product Code MWL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS145 Date Received04/06/2022 Decision Date05/03/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS143 Date Received03/31/2022 Decision Date04/27/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS044 Date Received04/18/2022 Decision Date04/27/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS005 Date Received03/28/2022 Decision Date04/26/2022 Product Code DSR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS091 Date Received03/31/2022 Decision Date04/25/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS013 Date Received03/25/2022 Decision Date04/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS061 Date Received03/16/2022 Decision Date04/15/2022 Product Code FHW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS002 Date Received09/20/2021 Decision Date04/14/2022 Product Code DSR  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS140 Date Received03/17/2022 Decision Date04/14/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• COOK MEDICAL INCORPORATEDsandet 6bjaeverskov 4632 PMA NumberP140016 Supplement NumberS005 Date Received03/18/2022 Decision Date04/14/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS004 Date Received03/17/2022 Decision Date04/12/2022 Product Code DSR  Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Cook Ireland, Ltd.o'halloran Roadnational Technology Parklimerick  PMA NumberP050017 Supplement NumberS019 Date Received03/07/2022 Decision Date04/04/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CARDIOFOCUS, INC.500 Nickerson Roadmarlborough, MA 01752 PMA NumberP150026 Supplement NumberS013 Date Received03/04/2022 Decision Date04/02/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Carl Zeiss Meditec Production LLC1040 South Vintage Avenue, Bldg. Aontario, CA 91761-3631 PMA NumberP100016 Supplement NumberS012 Date Received03/03/2022 Decision Date03/25/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• C.R. Bard, Inc1625 W. 3rd Streettempe, AZ 85528 PMA NumberP170042 Supplement NumberS011 Date Received08/20/2021 Decision Date03/24/2022 Product Code PFV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS210 Date Received02/08/2022 Decision Date03/11/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• CARDIOVASCULAR SYSTEMS, INC.651 Campus Drminneapolis, MN 55211 PMA NumberP130005 Supplement NumberS035 Date Received02/18/2022 Decision Date03/11/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS022 Date Received12/08/2021 Decision Date03/08/2022 Product Codes NIN NIO  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP150011 Supplement NumberS023 Date Received03/03/2022 Decision Date03/07/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP130011 Supplement NumberS010 Date Received03/03/2022 Decision Date03/07/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• CORCYM S.r.l.via Crescentino, Snsaluggia 13040 PMA NumberP900060 Supplement NumberS064 Date Received02/07/2022 Decision Date03/07/2022 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP970051 Supplement NumberS209 Date Received02/01/2022 Decision Date03/03/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS024 Date Received01/31/2022 Decision Date03/01/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS020 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIP  Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS045 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIO  Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS050 Date Received07/11/2022 Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• CornerStone Medical Serices-Midwest LLC
• CORNERSTONE MEDICAL SERVICES - MIDWEST, LLC
• Cornerstone Medical Services dba Cornerstone Medical Services-Midwest LLC
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