DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S012 · decided 2005-08-02
Approval details
- PMA number
- P000029
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- DEFLUX INJECTABLE GEL
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2005-04-08
- Decision date
- 2005-08-02
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR MODIFICATION OF THE POST APPROVAL STUDY PROTOCOL TO: 1) REPLACE THE 1- AND 5-YEAR VOIDING CYSTOURETHROGRAM MEASUREMENTS WITH CLINICAL ASSESSMENTS OF "FEBRILE UTI;" AND 2) DECREASE THE TOTAL SAMPLE SIZE FROM 200 TO 149 PATIENTS.
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 |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |