PMA P170027S006
- Device
- TherOx DownStream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S006
- Product code
- MWG
- Decision date
- 2021-12-09
- Generic name
- System, oxygen, aqueous
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- TherOx DownStream System
- Applicant
- Zoll Circulation, Inc.
- PMA number
- P170027
- Supplement
- S006
- Product code
- MWG
- Generic name
- System, oxygen, aqueous
- Decision date
- 2021-12-09
- Decision code
- APPR
- Date received
- 2021-05-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.