PMA P040050S010
- Device
- MACROPLASTIQUE IMPLANTS, MPQ-2.5
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S010
- Product code
- LNM
- Decision date
- 2012-12-28
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order 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.
Current openFDA PMA Record#
- Device
- MACROPLASTIQUE IMPLANTS, MPQ-2.5
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S010
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2012-12-28
- Decision code
- APPR
- Date received
- 2012-10-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.