TherOx Downstream System

FDA Premarket Approval P170027 S005

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

Approval for a manufacturing site located at zoll circulation facility (2000 ringwood ave, san jose, ca, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the therox® downstream® system console only.

DeviceTherOx Downstream System
Generic NameSystem, Oxygen, Aqueous
ApplicantTherOx, Inc.
Date Received2021-03-23
Decision Date2021-06-01
Product CodeMWG 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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
S005 2021-03-23 Normal 180 Day Track No User Fee
S004 2021-03-12 30-day Notice
S003 2021-02-25 30-day Notice
S002 2019-08-19 Normal 180 Day Track


Device IDPMASupp
20862478000463 P170027 000
20862478000456 P170027 000
20862478000449 P170027 000
20862478000432 P170027 000
10862478000428 P170027 000
00862478000414 P170027 000
00862478000407 P170027 000

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