PMA P040047S066

Device: COAPTITE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S066
Product code: LNM
Decision date: 2022-11-29
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom (Sturtevant, WI).

Current openFDA PMA Record#

Device: COAPTITE® Injectable Implant
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S066
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2022-11-29
Decision code: OK30
Date received: 2022-11-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the frequency of air particle sampling from the current three (3) times per month to one (1) time per month in the Merz Site 125 Cleanroom (Sturtevant, WI).