ARTEFILL® - PMMA COLLAGEN DERMAL FILLER
FDA premarket approval P020012/S006 · decided 2012-02-09
Approval details
- PMA number
- P020012
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARTEFILL® - PMMA COLLAGEN DERMAL FILLER
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2011-12-28
- Decision date
- 2012-02-09
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SUNEVA MEDIAL, INC. IN SAN DIEGO, CALIFORNIA
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