PROSORBA(TM) COLUMN
FDA premarket approval P850020 · decided 1987-12-23
Approval details
- PMA number
- P850020
- Trade name
- PROSORBA(TM) COLUMN
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 1985-04-02
- Decision date
- 1987-12-23
- Days to decision
- 995 days
- Decision code
- APWD
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
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