PROSORBA COLUMN
FDA premarket approval P850020/S021 · decided 2005-08-25
Approval details
- PMA number
- P850020
- Supplement
- S021
- 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
- 2005-07-26
- Decision date
- 2005-08-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE ART HEMOADSORPTION SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.
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