TherOx Downstream Console

FDA Premarket Approval P170027 S010

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

DeviceTherOx Downstream Console
Generic NameSystem, Oxygen, Aqueous
ApplicantTherOx, Inc.17500 Cartwright Rdsuite 100irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS010 Date Received09/30/2022 Decision Date10/27/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-30
Decision Date2022-10-27
PMAP170027
SupplementS010
Product CodeMWG 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTherOx, Inc.
17500 Cartwright Rd
suite 100
irvine, CA 92614-5846 PMA NumberP170027 Supplement NumberS010 Date Received09/30/2022 Decision Date10/27/2022 Product Code MWG  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For The Supplier Change Of The TherOx® DownStream® Console Model DS-2 Sub-assemblies Due To Impacts From COVID-19 Pandemic.

Supplemental Filings

Supplement NumberDateSupplement Type
P170027Original Filing
S010 2022-09-30 30-day Notice
S009 2021-12-17 Normal 180 Day Track
S008
S007
S006 2021-05-24 Normal 180 Day Track No User Fee
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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