PROSORBA COLUMN
FDA premarket approval P850020/S024 · decided 2006-10-19
Approval details
- PMA number
- P850020
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSORBA COLUMN
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 2006-09-18
- Decision date
- 2006-10-19
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- 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.
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