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

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
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
Titan Inflatable Penile Prosthesis (IPP)2022-04-15

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