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
• 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: S046
• Date Received: 10/12/2017
• Decision Date: 03/28/2018
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the alternate manufacturing facility located at 13900 W. Grandview Parkway Sturtevant.