SOLESTA INJECTABLE GEL
FDA premarket approval P100014 · decided 2011-05-27
Approval details
- PMA number
- P100014
- Trade name
- SOLESTA INJECTABLE GEL
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2010-04-09
- Decision date
- 2011-05-27
- Days to decision
- 413 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR THE SOLESTA. THIS DEVICE IS INDICATED FOR THE TREATMENT OF FECAL INCONTINENCE IN PATIENTS 18 YEARS AND OLDER WHO HAVE FAILED CONSERVATIVE THERAPY (E.G., DIET, FIBER THERAPY, ANTI-MOTILITY MEDICATIONS).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |