PMA P170027S020
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- Product code
- MWG
- Decision date
- 2025-10-29
- Generic name
- System, oxygen, aqueous
- Approval order statement
- approval of cleaning solution change for TherOx DownStream Cartridge Components due to current solution obsolescence
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S020
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2025-10-29
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of cleaning solution change for TherOx DownStream Cartridge Components due to current solution obsolescence