Bellafill Dermal Filler
FDA premarket approval P020012/S015 · decided 2017-09-28
Approval details
- PMA number
- P020012
- Supplement
- S015
- 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
- 2017-09-01
- Decision date
- 2017-09-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Removal of redundant quality control tests for SAN 8250 In-Process Tests with respect to PMMA.
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