PROSORBA COLUMN
FDA premarket approval P850020/S016 · decided 2003-02-12
Approval details
- PMA number
- P850020
- Supplement
- S016
- Supplement type
- Normal 180 Day 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
- 2002-08-16
- Decision date
- 2003-02-12
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR AN EXTENSION TO THE PROSORBA COLUMN'S EXPIRATION DATE FROM 12 MONTHS TO 18 MONTHS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.