Bellafill Dermal Filter
FDA premarket approval P020012/S013 · decided 2017-04-06
Approval details
- PMA number
- P020012
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bellafill Dermal Filter
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2017-03-06
- Decision date
- 2017-04-06
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- 1) Changed contract test lab and associated SOP for residual monomer in unprocessed PMMA microspheres; 2) Changed contract test lab and associated SOP for residual monomer in processed non-sterile PMMA microspheres; and 3) Added reference to internal manufacturing document and clarified rejectcriteria for finished product specification.
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