PMA P850020S018

Device
PROSORBA COLUMN
Applicant
Fresenius Hemocare, Inc.
PMA number
P850020
Supplement
S018
Product code
LKN
Decision date
2003-05-30
Generic name
Separator, automated, blood cell and plasma, therapeutic
Approval order statement
CHANGES TO THE STERILIZATION LOAD CONFIGURATION AND LENGTH OF STERILIZATION CYCLE.

Current openFDA PMA Record#

Device
PROSORBA COLUMN
Applicant
Fresenius Hemocare, Inc.
PMA number
P850020
Supplement
S018
Product code
LKN
Generic name
Separator, automated, blood cell and plasma, therapeutic
Decision date
2003-05-30
Decision code
OK30
Date received
2003-04-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO THE STERILIZATION LOAD CONFIGURATION AND LENGTH OF STERILIZATION CYCLE.