Macroplastique Implants
FDA premarket approval P040050/S013 · decided 2023-05-09
Approval details
- PMA number
- P040050
- Supplement
- S013
- 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
- 2022-05-13
- Decision date
- 2023-05-09
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for modifying the labeling to reflect the findings of the Macroplastique Real-Time Observation of Safety and Effectiveness (ROSE) Registry.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.