Macroplastique Implants
FDA premarket approval P040050/S012 · decided 2019-07-15
Approval details
- PMA number
- P040050
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Macroplastique Implants
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2019-04-17
- Decision date
- 2019-07-15
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for a modified formulation of the polymer resin used in the syringe barrel.
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