TherOx Downstream System
FDA premarket approval P170027/S007 · decided 2023-10-20
Approval details
- PMA number
- P170027
- Supplement
- S007
- 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
- 2021-07-01
- Decision date
- 2023-10-20
- Days to decision
- 841 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for addition of the TherOx SSO2 Catheter as an alternative catheter
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