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
PMAP170027
SupplementS005
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
S001

NIH GUDID Devices

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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