PMA P040047S078
- Device
- COAPTITE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S078
- Product code
- LNM
- Decision date
- 2025-08-27
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- two updates to the instructions for use of Coaptite
Current openFDA PMA Record#
- Device
- COAPTITE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S078
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2025-08-27
- Decision code
- APPR
- Date received
- 2025-07-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- two updates to the instructions for use of Coaptite