PMA P170027S014
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- Product code
- MWG
- Decision date
- 2024-10-03
- Generic name
- System, oxygen, aqueous
- Approval order statement
- a change to the Power Supply subsystem battery
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S014
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2024-10-03
- Decision code
- APPR
- Date received
- 2024-07-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a change to the Power Supply subsystem battery