Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10, COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10P
• Generic Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Applicant: Merz North America, Inc.; 4133 Ct.ney Rd., Suite 10; Franksville, WI 53126
• PMA Number: P040047
• Supplement Number: S024
• Date Received: 09/20/2012
• Decision Date: 10/18/2012
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDITION OF DEFECT CATEGORIES TO AN EXISTING INCOMING INSPECTION PROCEDURE.