MACROPLASTIQUE IMPLANTS, MPQ-2.5
FDA premarket approval P040050/S010 · decided 2012-12-28
Approval details
- PMA number
- P040050
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MACROPLASTIQUE IMPLANTS, MPQ-2.5
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2012-10-03
- Decision date
- 2012-12-28
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL TO QUALIFY AN ALTERNATIVE SILICONE ELASTOMER MATERIAL FOR THE MACROPLASTIQUE SYRINGE STOPPER, AS WELL AS AN ALTERNATIVE SUPPLIER OF THE SYRINGE STOPPER (NUSIL TECHNOLOGY, LLC AT CARPINTERIA, CA.) THERE IS NO CHANGE TO THE INDICATIONS FOR USE OR LABELING OF THE MACROPLASTIQUE DEVICE.
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