PMA P170027S009
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S009
- Product code
- MWG
- Decision date
- 2022-03-10
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Approval for a new material plasticizer for the tubing associated with the TherOx SSO2 DownStream Cartridge, part of the TherOx Downstream System.
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S009
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2022-03-10
- Decision code
- APPR
- Date received
- 2021-12-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new material plasticizer for the tubing associated with the TherOx SSO2 DownStream Cartridge, part of the TherOx Downstream System.