PMA P850020S015
- Device
- PROSORBA COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S015
- Product code
- LKN
- Decision date
- 2002-05-15
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Approval order statement
- REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS.
Current openFDA PMA Record#
- Device
- PROSORBA COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S015
- Product code
- LKN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Decision date
- 2002-05-15
- Decision code
- OK30
- Date received
- 2002-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS.