Bellafill Derma Filler
FDA premarket approval P020012/S027 · decided 2019-06-10
Approval details
- PMA number
- P020012
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Bellafill Derma Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2018-12-03
- Decision date
- 2019-06-10
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for a change in shipping container, shipping duration, and shipping temperature conditions of Bellafill Derma Filler.
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