PMA P940015S027

Device
SYNVISC AND SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S027
Product code
MOZ
Decision date
2013-06-28
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
INCREASE IN EXTRACT PRODUCTION.

Current openFDA PMA Record#

Device
SYNVISC AND SYNVISC-ONE
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S027
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2013-06-28
Decision code
OK30
Date received
2013-05-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
INCREASE IN EXTRACT PRODUCTION.