Bellafill Dermal Filler
FDA premarket approval P020012/S039 · decided 2022-02-17
Approval details
- PMA number
- P020012
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Bellafill Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2021-05-19
- Decision date
- 2022-02-17
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for a change in the syringe body from 1.0mL to 1.5mL, modified tray packaging, and a change in syringe cap lubricant.
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