PMA P040047S055

Device: Coaptite lnjectable lmplant
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S055
Product code: LNM
Decision date: 2019-11-06
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: Approval for modifications to the manufacturing equipment for Coaptite Injectable Implant, Radiesse Injectable Implant, and Radiesse (+) Lidocaine Dermal Filler.

Current openFDA PMA Record#

Device: Coaptite lnjectable lmplant
Applicant: Merz North America, Inc.
PMA number: P040047
Supplement: S055
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2019-11-06
Decision code: APPR
Date received: 2019-05-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the manufacturing equipment for Coaptite Injectable Implant, Radiesse Injectable Implant, and Radiesse (+) Lidocaine Dermal Filler.