PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN
FDA premarket approval P850020/S020 · decided 2005-08-17
Approval details
- PMA number
- P850020
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 2005-07-01
- Decision date
- 2005-08-17
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.
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