|
Device | PROSORBA COLUMN |
Generic Name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
Applicant | FRESENIUS HEMOCARE, INC. 920 WINTER STREET WALTHAM, MA 02451 |
PMA Number | P850020 |
Supplement Number | S023 |
Date Received | 04/14/2006 |
Decision Date | 05/11/2006 |
Withdrawal Date
|
04/14/2008 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN. |