PROSORBA COLUMN
FDA premarket approval P850020/S022 · decided 2006-06-22
Approval details
- PMA number
- P850020
- Supplement
- S022
- 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
- 2006-03-31
- Decision date
- 2006-06-22
- Days to decision
- 83 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 HAEMONETICS MCS AND HAEMONETICS MCS+ PLASMAPHERESIS SYSTEMS IN CONJUNCTION WITH THE PROSORBA COLUMN.
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