ARTEFILL
FDA premarket approval P020012/S007 · decided 2013-02-19
Approval details
- PMA number
- P020012
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ARTEFILL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2013-02-07
- Decision date
- 2013-02-19
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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