PMA P040047S082

Device: COAPTITE® AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S082
Product code: LNM
Decision date: 2026-05-14
Classification: Gastroenterology, Urology
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®

Current openFDA PMA Record#

Device: COAPTITE® AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S082
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2026-05-14
Decision code: OK30
Date received: 2026-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®