PMA P020012S011
- Device
- BELLAFILL PMMA COLLAGEN DERMAL FILLER
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S011
- Product code
- LMH
- Decision date
- 2015-08-07
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).
Current openFDA PMA Record#
- Device
- BELLAFILL PMMA COLLAGEN DERMAL FILLER
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S011
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2015-08-07
- Decision code
- APPR
- Date received
- 2015-02-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A CHANGE IN PRODUCT LABELING THAT DESCRIBED THE RESULTS OF YOUR 5-YEAR POST-APPROVAL STUDY (P521-01).