SCULPTRA
FDA premarket approval P030050/S001 · decided 2005-04-11
Approval details
- PMA number
- P030050
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SCULPTRA
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2004-10-04
- Decision date
- 2005-04-11
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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