PMA P040047S079
- Device
- COAPTITE
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S079
- Product code
- LNM
- Decision date
- 2025-12-12
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- The new Clean-In-Place (CIP) Spray Dryer System which automatically dose a measured amount of phosphoric acid to wash solution is approved.
Current openFDA PMA Record#
- Device
- COAPTITE
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S079
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2025-12-12
- Decision code
- OK30
- Date received
- 2025-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The new Clean-In-Place (CIP) Spray Dryer System which automatically dose a measured amount of phosphoric acid to wash solution is approved.