COAPTITE Injectable Impant
FDA premarket approval P040047/S067 · decided 2022-11-30
Approval details
- PMA number
- P040047
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COAPTITE Injectable Impant
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Merz North America, Inc.
- Date received
- 2022-11-01
- Decision date
- 2022-11-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- Addition of a modular ancillary cleanroom for device manufacturing.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |