SCULPTRA AND SCULPTRA AESTHETIC
FDA premarket approval P030050 · decided 2004-08-03
Approval details
- PMA number
- P030050
- Trade name
- SCULPTRA AND SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2003-12-01
- Decision date
- 2004-08-03
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- Yes
- Location
- Uppsala
- Statement
- APPROVAL FOR SCULPTRA. THE DEVICE IS INTENDED FOR RESTORATION AND/OR CORRECTION OF THE SIGNS OF FACIAL FAT LOSS (LIPOATROPHY) IN PEOPLE WITH HUMAN IMMUNODEFICIENCY VIRUS.
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