PMA P040050S011
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S011
- Product code
- LNM
- Decision date
- 2014-09-16
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- ADDITION OF AN ALTERNATIVE BACTERIAL ENDOTOXIN TESTING FACILITY.
Current openFDA PMA Record#
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S011
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-09-16
- Decision code
- OK30
- Date received
- 2014-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATIVE BACTERIAL ENDOTOXIN TESTING FACILITY.