PMA P040047

Device: COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S069
Product code: LNM
Decision date: 2026-06-26
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
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.

Current openFDA PMA Record#

Device: COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S083
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2026-06-26
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.