MACROPLASTIQUE IMPLANTS
FDA premarket approval P040050/S007 · decided 2011-02-04
Approval details
- PMA number
- P040050
- Supplement
- S007
- 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
- 2010-11-24
- Decision date
- 2011-02-04
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR A CONTRACT GAMMA STERILIZATION SITE LOCATED AT STERIS/ISOMEDIX CONTRACT STERILIZATION SERVICES, LIBERTYVILLE, ILLINOIS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.