Bellafill Dermal Filler
FDA premarket approval P020012/S048 · decided 2025-01-07
Approval details
- PMA number
- P020012
- Supplement
- S048
- 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
- 2024-12-09
- Decision date
- 2025-01-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for changes to SDS-PAGE collagen analysis test equipment used during subassembly manufacturing
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.