SCULPTRA AND SCULPTRA AESTHETIC
FDA premarket approval P030050/S018 · decided 2013-08-16
Approval details
- PMA number
- P030050
- Supplement
- S018
- 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
- 2013-07-22
- Decision date
- 2013-08-16
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- THE FOLLOWING CHANGES: 1) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION OF STERILIZATION AT THE DAGNEUX FRANCE FACILITY; 2) PACKAGING MODIFICATION FOR THE RAW MATERIAL, INCLUDING A NEW BAG SUPPLIER AND THE INTRODUCTION OF A NEW BAGGING CONFIGURATION; AND 3) REPLACEMENT OF THE GAMMA RADIATION SOURCE AND REQUALIFICATION AT THE SABLÉ FRANCE FACILITY.
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