PMA P040047S076
- Device
- Coaptite
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S076
- Product code
- LNM
- Decision date
- 2025-04-01
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- approval for layout modifications of the existing cleanroom
Current openFDA PMA Record#
- Device
- Coaptite
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S076
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2025-04-01
- Decision code
- OK30
- Date received
- 2025-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for layout modifications of the existing cleanroom