PROSORBA TREATMENT COLUMN FOR RA AND ITP
FDA premarket approval P850020/S012 · decided 1999-12-17
Approval details
- PMA number
- P850020
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PROSORBA TREATMENT COLUMN FOR RA AND ITP
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 1999-06-21
- Decision date
- 1999-12-17
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- Approval of post-approval study protocols.
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