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. |
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Device | PROSORBA COLUMN |
Generic Name | Separator, automated, blood cell and plasma, therapeutic |
Applicant | FRESENIUS HEMOCARE, INC. 920 WINTER STREET WALTHAM, MA 02451 |
PMA Number | P850020 |
Supplement Number | S017 |
Date Received | 04/15/2003 |
Decision Date | 04/15/2004 |
Withdrawal Date
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04/14/2008 |
Product Code |
LKN |
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 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS. |
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