Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | SYNVISC & SYNVISC-ONE |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S020 |
Date Received | 02/16/2011 |
Decision Date | 03/18/2011 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |
|
|