PROSORBA COLUMN
FDA premarket approval P850020/S013 · decided 2001-10-26
Approval details
- PMA number
- P850020
- Supplement
- S013
- Supplement type
- Normal 180 Day 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
- 2001-04-30
- Decision date
- 2001-10-26
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR REVISED LABELING THAT RELATES NEW POST-MARKET SAFETY INFORMATION REGARDING EPISODES OF VASCULITIS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH THE PROSORBA(R) COLUMN.
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