|
Device | 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 | S017 |
Date Received | 01/29/2010 |
Decision Date | 03/12/2010 |
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 CHANGE TO THE AUTOMATED FILLING PROCESS FOR THE SYNVISC-ONE SYRINGES FROM USING THE COZZOLI FILLER TO USING THE INOVA VACUUM FILLER. |