PMA P020012S008
- Device
- BELLAFILL
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S008
- Product code
- LMH
- Decision date
- 2013-08-27
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR A CHANGE IN THE TRADE NAME OF YOUR PRODUCT FROM ARTEFILL® TO BELLAFILL®.
Current openFDA PMA Record#
- Device
- BELLAFILL
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S008
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2013-08-27
- Decision code
- APPR
- Date received
- 2013-08-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE TRADE NAME OF YOUR PRODUCT FROM ARTEFILL® TO BELLAFILL®.