- Device
- TherOx® DownStream® Cartridge (DSC-2)
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S012
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2024-06-06
- Decision code
- APPR
- Date received
- 2023-11-03
- 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® Cartridge