TherOx Downstream System
FDA premarket approval P170027/S009 · decided 2022-03-10
Approval details
- PMA number
- P170027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2021-12-17
- Decision date
- 2022-03-10
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for a new material plasticizer for the tubing associated with the TherOx SSO2 DownStream Cartridge, part of the TherOx Downstream System.
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