PMA P940015S017

Device
SYNVISC-ONE (HYLAN G-F 20)
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S017
Product code
MOZ
Decision date
2010-03-12
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
CHANGE TO THE AUTOMATED FILLING PROCESS FOR THE SYNVISC-ONE SYRINGES FROM USING THE COZZOLI FILLER TO USING THE INOVA VACUUM FILLER.

Current openFDA PMA Record#

Device
SYNVISC-ONE (HYLAN G-F 20)
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S017
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2010-03-12
Decision code
OK30
Date received
2010-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE AUTOMATED FILLING PROCESS FOR THE SYNVISC-ONE SYRINGES FROM USING THE COZZOLI FILLER TO USING THE INOVA VACUUM FILLER.