PMA P020012S029
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S029
- Product code
- LMH
- Decision date
- 2019-05-03
- Classification
- Implant, Dermal, For Aesthetic Use
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for an added warning for periocular use.
Current openFDA PMA Record#
- Device
- Bellafill Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S029
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2019-05-03
- Decision code
- APPR
- Date received
- 2019-04-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an added warning for periocular use.