This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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.
|Device||TherOx Downstream System|
|Generic Name||System, Oxygen, Aqueous|
|Supplement Type||Normal 180 Day Track|
|Supplement Reason||Change Design/components/specifications/material|
|Applicant Address||TherOx, Inc. 17500 Cartwright Rd suite 100 irvine, CA 92614-5846|
|Supplement Number||Date||Supplement Type|
|S002||2019-08-19||Normal 180 Day Track|