SCULPTRA AESTHETIC
FDA premarket approval P030050/S008 · decided 2010-09-09
Approval details
- PMA number
- P030050
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2010-05-19
- Decision date
- 2010-09-09
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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