PMA P170027S017
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- Product code
- MWG
- Decision date
- 2024-12-19
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Approval for additional inspection step in the manufacturing process approval for the Cartridge Chambers and Cartridge Oxygen Port Filter.
Current openFDA PMA Record
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S017
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2024-12-19
- Decision code
- APPR
- Date received
- 2024-11-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional inspection step in the manufacturing process approval for the Cartridge Chambers and Cartridge Oxygen Port Filter.