COAPTITE Injectable Implant
FDA premarket approval P040047/S078 · decided 2025-08-27
Approval details
- PMA number
- P040047
- Supplement
- S078
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COAPTITE Injectable Implant
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Merz North America, Inc.
- Date received
- 2025-07-28
- Decision date
- 2025-08-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- two updates to the instructions for use of Coaptite
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |