PMA P940015S030

Device
SYNVISC
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S030
Product code
MOZ
Decision date
2013-12-05
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
USE OF ALTERNATE EQUIPMENT FOR FILLING SYRINGES.

Current openFDA PMA Record#

Device
SYNVISC
Applicant
Sanofi Genzyme Corp.
PMA number
P940015
Supplement
S030
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2013-12-05
Decision code
OK30
Date received
2013-11-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF ALTERNATE EQUIPMENT FOR FILLING SYRINGES.