PMA P040050S012
- Device
- Macroplastique Implants
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S012
- Product code
- LNM
- Decision date
- 2019-07-15
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for a modified formulation of the polymer resin used in the syringe barrel.
Current openFDA PMA Record#
- Device
- Macroplastique Implants
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S012
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2019-07-15
- Decision code
- APPR
- Date received
- 2019-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modified formulation of the polymer resin used in the syringe barrel.