PMA P040050S003
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S003
- Product code
- LNM
- Decision date
- 2009-06-26
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO REFLECT THE FINDINGS OF THE ENHANCED SURVEILLANCE STUDY.
Current openFDA PMA Record#
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S003
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2009-06-26
- Decision code
- APPR
- Date received
- 2009-02-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO REFLECT THE FINDINGS OF THE ENHANCED SURVEILLANCE STUDY.