PMA P040050S001
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S001
- Product code
- LNM
- Decision date
- 2007-07-27
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE FROM MINNEAPOLIS, MINNESOTA TO MINNETONKA, MINNESOTA.
Current openFDA PMA Record#
- Device
- MACROPLASTIQUE IMPLANTS
- Applicant
- Uroplasty, LLC
- PMA number
- P040050
- Supplement
- S001
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2007-07-27
- Decision code
- APPR
- Date received
- 2007-03-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE FROM MINNEAPOLIS, MINNESOTA TO MINNETONKA, MINNESOTA.