Bellafill Dermal Filler
FDA premarket approval P020012/S046 · decided 2024-02-27
Approval details
- PMA number
- P020012
- Supplement
- S046
- 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
- 2024-01-31
- Decision date
- 2024-02-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- implement the supplier's change to the sterilization method and minor dimensional changes for a part, the Crimp Cap P/N 3017, a cap for a material container used in subassembly manufacturing
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