ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
FDA premarket approval P020012/S012 · decided 2016-04-21
Approval details
- PMA number
- P020012
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2016-02-24
- Decision date
- 2016-04-21
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for changes in the manufacturing process to remove a sampling step, split sterilization batch records, and add re-sieving steps.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.