MACROPLASTIQUE IMPLANTS
FDA premarket approval P040050/S011 · decided 2014-09-16
Approval details
- PMA number
- P040050
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MACROPLASTIQUE IMPLANTS
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2014-08-19
- Decision date
- 2014-09-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- ADDITION OF AN ALTERNATIVE BACTERIAL ENDOTOXIN TESTING FACILITY.
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