PROSORBA COLUMN
FDA premarket approval P850020/S017 · decided 2004-04-15
Approval details
- PMA number
- P850020
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSORBA COLUMN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 2003-04-15
- Decision date
- 2004-04-15
- Days to decision
- 366 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- 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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