PMA P170027S007
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- Product code
- MWG
- Decision date
- 2023-10-20
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Approval for addition of the TherOx SSO2 Catheter as an alternative catheter
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S007
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2023-10-20
- Decision code
- APPR
- Date received
- 2021-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of the TherOx SSO2 Catheter as an alternative catheter