PMA P040050S013
- Device
- Macroplastique Implants
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S013
- Product code
- LNM
- Decision date
- 2023-05-09
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for modifying the labeling to reflect the findings of the Macroplastique Real-Time Observation of Safety and Effectiveness (ROSE) Registry.
Current openFDA PMA Record#
- Device
- Macroplastique Implants
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S013
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2023-05-09
- Decision code
- APPR
- Date received
- 2022-05-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modifying the labeling to reflect the findings of the Macroplastique Real-Time Observation of Safety and Effectiveness (ROSE) Registry.