PMA P170027S011

Device: TherOx Downstream System
Applicant: Zoll Circulation, Inc.
Product code: MWG
Decision date: 2024-06-06
Generic name: System, oxygen, aqueous
Approval order statement: Approval for a manufacturing site located at ZOLL Circulation Facility (ERN/FEI: 301061700, 2000 Ringwood Ave, San Jose, CA, 95131) for the manufacturing of the TherOx® DownStream® Console sub-assemblies

Current openFDA PMA Record

Device: TherOx Downstream System
Applicant: Zoll Circulation, Inc.
PMA number: P170027
Supplement: S011
Product code: MWG
Generic name: System, oxygen, aqueous
Decision date: 2024-06-06
Decision code: APPR
Date received: 2023-09-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at ZOLL Circulation Facility (ERN/FEI: 301061700, 2000 Ringwood Ave, San Jose, CA, 95131) for the manufacturing of the TherOx® DownStream® Console sub-assemblies