MACROPLASTIQUE IMPLANTS
FDA premarket approval P040050/S001 · decided 2007-07-27
Approval details
- PMA number
- P040050
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MACROPLASTIQUE IMPLANTS
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2007-03-02
- Decision date
- 2007-07-27
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE FROM MINNEAPOLIS, MINNESOTA TO MINNETONKA, MINNESOTA.
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