PMA P040047S067
- Device
- COAPTITE Injectable Impant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S067
- Product code
- LNM
- Decision date
- 2022-11-30
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Addition of a modular ancillary cleanroom for device manufacturing.
Current openFDA PMA Record#
- Device
- COAPTITE Injectable Impant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S067
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2022-11-30
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a modular ancillary cleanroom for device manufacturing.