Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S024 |
Date Received | 09/18/2006 |
Decision Date | 10/19/2006 |
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 LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3) A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING. |
|
|