Bellafill® Dermal Filler
FDA premarket approval P020012/S041 · decided 2022-08-05
Approval details
- PMA number
- P020012
- Supplement
- S041
- 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
- 2022-07-08
- Decision date
- 2022-08-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Implementing an alternate particle testing method as the primary test method for PMMA microsphere count and size distribution testing.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.