This page includes the latest FDA filings for 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. 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 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 | Titan Inflatable Penile Prosthesis (IPP) | 2022-08-24 |