PROSORBA(TM) COLUMN
FDA premarket approval P850020/S009 · decided 1997-04-17
Approval details
- PMA number
- P850020
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSORBA(TM) COLUMN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 1997-03-07
- Decision date
- 1997-04-17
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR THE CONSOLIDATION OF MANUFACTURING OPERATIONS AT CYPRESS BIOSCIENCE, 14787 NE 95TH ST., REDMOND, WA 98052.
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