Bellafill Dermal Filler
FDA premarket approval P020012/S034 · decided 2019-10-01
Approval details
- PMA number
- P020012
- Supplement
- S034
- 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
- 2019-09-17
- Decision date
- 2019-10-01
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Implement a change on the Sampling and Monitoring plan for the USP Purified Water and Pure Steam WFI in the Suneva Medical facility at San Diego, California.
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