Bellafill Dermal Filler
FDA premarket approval P020012/S038 · decided 2021-05-14
Approval details
- PMA number
- P020012
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bellafill Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2021-04-16
- Decision date
- 2021-05-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Implementation of a new chromatography equipment for hydroxyproline/collagen content and lidocaine hydrochloride content in-process and lot release quality control testing.
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