PMA P940015S020

Device
SYNVISC & SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S020
Product code
MOZ
Decision date
2011-03-18
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
FILLING OF AN INVESTIGATIONAL DRUG ON THE INOVA FILLER MACHINE, WHICH IS ALSO USED FOR FILLING THE SYNVISC AND SYNVISC-ONE PRODUCTS.
Summary
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Current openFDA PMA Record#

Device
SYNVISC & SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S020
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2011-03-18
Decision code
OK30
Date received
2011-02-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
FILLING OF AN INVESTIGATIONAL DRUG ON THE INOVA FILLER MACHINE, WHICH IS ALSO USED FOR FILLING THE SYNVISC AND SYNVISC-ONE PRODUCTS.