PMA P040047S070
- Device
- Coaptite Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S070
- Product code
- LNM
- Decision date
- 2024-01-25
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for a change to the in-process testing to determine moisture.
Current openFDA PMA Record#
- Device
- Coaptite Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S070
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2024-01-25
- Decision code
- APPR
- Date received
- 2023-01-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the in-process testing to determine moisture.