FDA.reportPublic FDA data

PMA P170027S002

Device
TherOx Downstream System
Applicant
Zoll Circulation, Inc.
PMA number
P170027
Supplement
S002
Product code
MWG
Decision date
2020-03-11
Generic name
System, oxygen, aqueous
Approval order statement
Approval for the DS-2 Console. The DS-2 Console uses the same cartridge as the DS-1 Console; however, it has updated hardware and software to accommodate a touchscreen display in addition to modified electrical components to comply with the EU RoHS Standard.

Current openFDA PMA Record#

Device
TherOx Downstream System
Applicant
Zoll Circulation, Inc.
PMA number
P170027
Supplement
S002
Product code
MWG
Generic name
System, oxygen, aqueous
Decision date
2020-03-11
Decision code
APPR
Date received
2019-08-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the DS-2 Console. The DS-2 Console uses the same cartridge as the DS-1 Console; however, it has updated hardware and software to accommodate a touchscreen display in addition to modified electrical components to comply with the EU RoHS Standard.