PMA P030032S010

Device: PREVELLE SILK
Applicant: Genzyme Biosurgery
PMA number: P030032
Supplement: S010
Product code: LMH
Decision date: 2010-09-15
Generic name: Implant, dermal, for aesthetic use
Approval order statement: P940015/S0199/15/10135-DAY SYNVISC/SYNVISC-ONE AND PREVELLE SILK GENZYME BIOSURGERYCAMBRIDGE, MA02142 APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.

Current openFDA PMA Record#

Device: PREVELLE SILK
Applicant: Genzyme Biosurgery
PMA number: P030032
Supplement: S010
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2010-09-15
Decision code: APPR
Date received: 2010-06-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: P940015/S0199/15/10135-DAY SYNVISC/SYNVISC-ONE AND PREVELLE SILK GENZYME BIOSURGERYCAMBRIDGE, MA02142 APPROVAL FOR A MANUFACTURING CHANGE INVOLVING INSTALLATION OF THE WATERS EMPOWER 2 CHROMATOGRAPHY DATA SYSTEM.