PMA P940015S019

Device: SYNVISC & SYNVISC-ONE
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S019
Product code: MOZ
Decision date: 2010-09-15
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
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: SYNVISC & SYNVISC-ONE
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S019
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
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.