MACROPLASTIQUE IMPLANTS
FDA premarket approval P040050/S003 · decided 2009-06-26
Approval details
- PMA number
- P040050
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MACROPLASTIQUE IMPLANTS
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2009-02-18
- Decision date
- 2009-06-26
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO REFLECT THE FINDINGS OF THE ENHANCED SURVEILLANCE STUDY.
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