SCULPTRA AND SCULPTRA Aesthetic
FDA premarket approval P030050/S026 · decided 2017-06-09
Approval details
- PMA number
- P030050
- Supplement
- S026
- Supplement type
- 135 Review Track For 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
- 2017-02-08
- Decision date
- 2017-06-09
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- Approval for the installation of a restricted access barrier system for aseptic filling.
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