PMA P850020S016
- Device
- PROSORBA COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S016
- Product code
- LKN
- Decision date
- 2003-02-12
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Approval order statement
- APPROVAL FOR AN EXTENSION TO THE PROSORBA COLUMN'S EXPIRATION DATE FROM 12 MONTHS TO 18 MONTHS.
Current openFDA PMA Record#
- Device
- PROSORBA COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S016
- Product code
- LKN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Decision date
- 2003-02-12
- Decision code
- APPR
- Date received
- 2002-08-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN EXTENSION TO THE PROSORBA COLUMN'S EXPIRATION DATE FROM 12 MONTHS TO 18 MONTHS.