Bellafill Dermal Filler
FDA premarket approval P020012/S044 · decided 2023-05-19
Approval details
- PMA number
- P020012
- Supplement
- S044
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Bellafill Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2023-04-19
- Decision date
- 2023-05-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for revisions to the instructions for use of Bellafill Dermal Filler as a result of postmarket surveillance data.
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