PMA P170027S010
- Device
- TherOx Downstream Console
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S010
- Product code
- MWG
- Decision date
- 2022-10-27
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Supplier change of the TherOx® DownStream® Console Model DS-2 sub-assemblies due to impacts from COVID-19 pandemic.
Current openFDA PMA Record#
- Device
- TherOx Downstream Console
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S010
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2022-10-27
- Decision code
- OK30
- Date received
- 2022-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change of the TherOx® DownStream® Console Model DS-2 sub-assemblies due to impacts from COVID-19 pandemic.