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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® Agent, Bulking, Injectable For Gastro-Urology Use
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantMerz North America, Inc.
4133 Ct.Ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP040047
Supplement NumberS083
Date Received05/28/2026
Decision Date06/26/2026
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
modification of the Dynamic Crossflow Filtration (DCF) System for use in calcium hydroxylapatite (CaHA) particle manufacturing for the Radiesse, Radiesse (+), and Coaptite product lines.
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