TherOx Downstream System

FDA Premarket Approval P170027 S002

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.

Pre-market Approval Supplement Details

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.

DeviceTherOx Downstream System
Generic NameSystem, Oxygen, Aqueous
ApplicantTherOx, Inc.
Date Received2019-08-19
Decision Date2020-03-11
Product CodeMWG 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address TherOx, Inc. 17500 Cartwright Rd suite 100 irvine, CA 92614-5846

Supplemental Filings

Supplement NumberDateSupplement Type
P170027Original Filing
S002 2019-08-19 Normal 180 Day Track

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