SCULPTRA AND SCULPTRA AESTHETIC
FDA premarket approval P030050/S024 · decided 2016-07-07
Approval details
- PMA number
- P030050
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA AND SCULPTRA AESTHETIC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2016-06-10
- Decision date
- 2016-07-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Change to the sterility testing method.
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