SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)
FDA premarket approval P030050/S019 · decided 2014-01-23
Approval details
- PMA number
- P030050
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2013-12-23
- Decision date
- 2014-01-23
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- CHANGES TO THE SIEVING YIELD RANGE AND A MODIFICATION OF THE STIRRING SYSTEM FOR CLOGGING TEST.
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