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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCOAPTITE Injectable Implant
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP040047
Supplement NumberS061
Date Received09/18/2020
Decision Date10/15/2020
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Adding Merz North America as an alternate facility to perform microbial analysis of water in the microbiology laboratory at manufacturing sites of COAPTITE, RADIESSE, and RADIESSE (+) Lidocaine.
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