COAPTITE
FDA premarket approval P040047 · decided 2005-11-10
Approval details
- PMA number
- P040047
- Trade name
- COAPTITE
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Merz North America, Inc.
- Date received
- 2004-12-09
- Decision date
- 2005-11-10
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- APPROVAL FOR COAPTITE. THE DEVICE IS INDICATED FOR SOFT TISSUE AUGMENTATION IN THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD) IN ADULT FEMALES.
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 |