PMA P170027S016
Current openFDA PMA Record
- Device
- TherOx DownStream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S016
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2024-12-11
- Decision code
- OK30
- Date received
- 2024-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- partial relocation of Catheter manufacturing process steps and process improvement in current bioburden monitoring process