Bellafill Dermal Filler
FDA premarket approval P020012/S032 · decided 2019-12-18
Approval details
- PMA number
- P020012
- Supplement
- S032
- Supplement type
- Real-Time Process
- 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
- 2019-06-13
- Decision date
- 2019-12-18
- Days to decision
- 188 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval to implement a change in raw material specifications for hydrochloric acid, sodium chloride, acetic acid, and citric acid monohydrate
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