|
Trade Name | EXCORIM IMMUNOADSORPTION SYSTEM |
Classification Name | columns, immunoadsorption in extracorporeal systems |
Generic Name | columns, immunoadsorption in extracorporeal systems |
Applicant |
FRESENIUS MEDICAL CARE |
95 hayden ave. |
lexington, MA 02420 |
|
HDE Number | H970004 |
Supplement Number | S001 |
Date Received | 11/17/1998 |
Decision Date | 12/17/1999 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change in the ethylene oxide sterilization site for the medical lines. |