This page includes the latest FDA filings for 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. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
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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 | Titan Inflatable Penile Prosthesis (IPP) | 2023-01-12 |