- Device
- COAPTITE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S063
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-10-23
- Decision code
- OK30
- Date received
- 2020-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Permission for Merz NA to inspect incoming Glycerin raw material in-house in alignment with the USP-NF Glycerin Monograph used in COAPTITE, RADIESSE, and RADIESSE (+) products.