SOLESTA
FDA premarket approval P100014/S007 · decided 2012-04-12
Approval details
- PMA number
- P100014
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Trade name
- SOLESTA
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2012-03-30
- Decision date
- 2012-04-12
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- ADDITION OF THE POSSIBILITY TO STORE SAMPLES FOR BIOBURDEN ANALYSIS IN A REFRIGERATOR AT A TEMPERATURE OF 5 DEGREE CELSIUS FOR UP TO 18 HOURS BEFORE ANALYSIS.
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| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |