SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)
FDA premarket approval P030050/S017 · decided 2014-10-10
Approval details
- PMA number
- P030050
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2013-04-05
- Decision date
- 2014-10-10
- Days to decision
- 553 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- APPROVAL FOR A CHANGE IN PRODUCT LABELING TO DESCRIBE THE RESULTS OF A POSTAPPROVAL STUDY IN PATIENTS WITH HIV ASSOCIATED LIPOATROPHY.
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