Bellafill Dermal Filler
FDA premarket approval P020012/S040 · decided 2022-01-21
Approval details
- PMA number
- P020012
- Supplement
- S040
- Supplement type
- 135 Review Track For 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
- 2021-08-20
- Decision date
- 2022-01-21
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval to add an alternate supplier for NaOH used in the manufacture of the device.
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