PMA P170027S003
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S003
- Product code
- MWG
- Decision date
- 2021-03-26
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Change to the catheter qualification process.
Current openFDA PMA Record#
- Device
- TherOx Downstream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S003
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2021-03-26
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the catheter qualification process.