SCULPTRA
FDA premarket approval P030050/S006 · decided 2009-12-02
Approval details
- PMA number
- P030050
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SCULPTRA
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2009-10-09
- Decision date
- 2009-12-02
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR REVISION OF THE SCULPTRA PHYSICIAN AND PATIENT LABELING.
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