SCULPTRA Aesthetic (injectable poly-L Lactic acid)
FDA premarket approval P030050/S028 · decided 2018-05-01
Approval details
- PMA number
- P030050
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SCULPTRA Aesthetic (injectable poly-L Lactic acid)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2017-12-05
- Decision date
- 2018-05-01
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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