DEFLUX SYRINGE
FDA premarket approval P000029/S014 · decided 2005-10-28
Approval details
- PMA number
- P000029
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEFLUX SYRINGE
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2005-10-06
- Decision date
- 2005-10-28
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- ADDITION OF AN IN-PROCESS CONTROL TO REPLACE A TEST PROCEDURE FOR USAGE DURING ORDINARY MANUFACTURING.
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