PMA P940015S025

Device
SYNVISC & SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S025
Product code
MOZ
Decision date
2012-05-03
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.

Current openFDA PMA Record#

Device
SYNVISC & SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S025
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2012-05-03
Decision code
APPR
Date received
2011-12-20
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE ADDITION OF A NEW PRODUCT DATA AND LABORATORY INFORMATION MANAGEMENT SYSTEM.