PMA P040047S077
- Device
- COAPTITE®
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S077
- Product code
- LNM
- Decision date
- 2025-06-16
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- addition of a Continuous Electronic Deionized (CEDI) System
Current openFDA PMA Record#
- Device
- COAPTITE®
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S077
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2025-06-16
- Decision code
- OK30
- Date received
- 2025-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a Continuous Electronic Deionized (CEDI) System