SCULPTRA & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID)
FDA premarket approval P030050/S020 · decided 2014-02-19
Approval details
- PMA number
- P030050
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SCULPTRA & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID)
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2014-01-22
- Decision date
- 2014-02-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- Statement
- REPLACEMENT OF THE RADIATION SOURCE AND SUBSEQUENT REQUALIFICATION OF THE RADIATION PROCESS AT THE FIRM¿S CONTRACT STERILIZER FACILITY.
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