PMA P030050S020

Device: SCULPTRA & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID)
Applicant: Q-Med AB
PMA number: P030050
Supplement: S020
Product code: LMH
Decision date: 2014-02-19
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: REPLACEMENT OF THE RADIATION SOURCE AND SUBSEQUENT REQUALIFICATION OF THE RADIATION PROCESS AT THE FIRM¿S CONTRACT STERILIZER FACILITY.

Current openFDA PMA Record#

Device: SCULPTRA & SCULPTRA AESTHETIC ( INJECTABLE POLY-L LACTIC ACID)
Applicant: Q-Med AB
PMA number: P030050
Supplement: S020
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2014-02-19
Decision code: OK30
Date received: 2014-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF THE RADIATION SOURCE AND SUBSEQUENT REQUALIFICATION OF THE RADIATION PROCESS AT THE FIRM¿S CONTRACT STERILIZER FACILITY.