TherOx Downstream System

FDA Premarket Approval P170027 S004

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

A single use packaging design for the fully assembled one-piece console

• Device: TherOx Downstream System
• Generic Name: System, Oxygen, Aqueous
• Applicant: TherOx, Inc.
• Date Received: 2021-03-12
• Decision Date: 2021-03-29
• PMA: P170027
• Supplement: S004
• Product Code: MWG
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: TherOx, Inc. 17500 Cartwright Rd suite 100 irvine, CA 92614-5846

Supplemental Filings

Supplement Number	Date	Supplement Type
P170027		Original 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 ID	PMA	Supp
20862478000463	P170027	000
20862478000456	P170027	000
20862478000449	P170027	000
20862478000432	P170027	000
10862478000428	P170027	000
00862478000414	P170027	000
00862478000407	P170027	000