|
Device | SYNVISC |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S013 |
Date Received | 09/25/2008 |
Decision Date | 04/10/2009 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE RELOCATION OF MANUFACTURING PROCESSES WITHIN THE SAME FACILITY AND THE ADDITION OF AN ALTERNATE SYRINGE FILLING MACHINE. |