|
Device | SYNVISC & SYNVISC-ONE (HYLAN G-F 20) |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Sanofi GENZYME CORP. 50 Binney Street Cambridge, MA 02142 |
PMA Number | P940015 |
Supplement Number | S023 |
Date Received | 09/02/2011 |
Decision Date | 10/07/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF A RAW MATERIAL IDENTIFICATION SYSTEM AND AN AUTOMATED FILTER INTEGRITY TEST INSTRUMENT. |