COAPTITE
FDA premarket approval P040047/S042 · decided 2015-10-01
Approval details
- PMA number
- P040047
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COAPTITE
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Merz North America, Inc.
- Date received
- 2015-09-04
- Decision date
- 2015-10-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- LIFTING THE REQUIREMENT THAT MANUFACTURING EQUIPMENT REMAIN DEDICATED TO SPECIFIC PRODUCTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |