SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID)
FDA premarket approval P030050/S010 · decided 2011-06-14
Approval details
- PMA number
- P030050
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) & SCULPTRA AESTHETIC (INJECTABLE POLY -L-LACTIC ACID)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2011-03-25
- Decision date
- 2011-06-14
- Days to decision
- 81 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- CHANGE THE LOCATION OF THE DESIGN CONTROL CENTER FOR SCULPTRA AND SCULPTRA AETHETIC FROM SANOFI AVENTIS U.S. LLC TO ANAGNI ITALY.
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