PMA P170027S008
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- Product code
- MWG
- Decision date
- 2023-03-09
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Approval of the refurbishment process for DS-2 Consoles meant to be used in the TherOx DownStream System
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S008
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2023-03-09
- Decision code
- APPR
- Date received
- 2021-11-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of the refurbishment process for DS-2 Consoles meant to be used in the TherOx DownStream System