PROSORBA COLUMN
FDA premarket approval P850020/S023 · decided 2006-05-11
Approval details
- PMA number
- P850020
- Supplement
- S023
- 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
- 2006-04-14
- Decision date
- 2006-05-11
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.
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