Bellafill Dermal Filler
FDA premarket approval P020012/S017 · decided 2018-01-02
Approval details
- PMA number
- P020012
- Supplement
- S017
- 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
- 2017-12-04
- Decision date
- 2018-01-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Modification of the Bellafill tray by adding: 1) a stop shelf in the molded tray at a slight diagonal orientation to align the plunger end of the syringes; and 2) a flange indentation for placement of each syringe flange.
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