|
|
| Device Name |
Company |
Date Approved |
Supplement Reason |
Other Information |
|
Sanofi Genzyme Corp. |
Aug 08, 1997 |
|
Approval Order Summary of Safety & Effectiveness Labeling & Labeling 2
|
|
Sanofi Genzyme Corp. |
Nov 05, 1998 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Feb 19, 1999 |
location change - manufacturer/sterilizer/packager/supplier
|
|
|
Sanofi Genzyme Corp. |
Dec 20, 1999 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
May 26, 1999 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Sep 12, 2000 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Sep 26, 2003 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Apr 26, 2002 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Jul 09, 2003 |
labeling change - indications/instructions/shelf life/tradename
|
|
|
Sanofi Genzyme Corp. |
Mar 14, 2003 |
labeling change - indications/instructions/shelf life/tradename
|
|