TherOx Downstream System
FDA premarket approval P170027/S014 · decided 2024-10-03
Approval details
- PMA number
- P170027
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2024-07-16
- Decision date
- 2024-10-03
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- a change to the Power Supply subsystem battery
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