Bellafill Dermal Filler
FDA premarket approval P020012/S037 · decided 2021-06-08
Approval details
- PMA number
- P020012
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Bellafill Dermal Filler
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2021-02-10
- Decision date
- 2021-06-08
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for change in secondary packaging tray lid material for the Bellafill Dermal Filler Treatment Kit and the Skin Test Kit, and change in co-packaged needle to TSK Steriject 27G Thin Wall needle for the Bellafill Dermal Filler Treatment Kit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.