- Device
- PROSORBA PROTEIN A IMMUNOADSORPTION COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S020
- Product code
- LKN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Decision date
- 2005-08-17
- Decision code
- APPR
- Date received
- 2005-07-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.