PMA P170027S015

Current openFDA PMA Record

Device: TherOx DownStream System
Applicant: Zoll Circulation, Inc.
PMA number: P170027
Supplement: S015
Product code: MWG
Generic name: System, oxygen, aqueous
Decision date: 2024-08-14
Decision code: OK30
Date received: 2024-07-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the location for the SSO2 delivery Catheter lot-release quality control testing equipment