TherOx Downstream System
FDA premarket approval P170027/S002 · decided 2020-03-11
Approval details
- PMA number
- P170027
- Supplement
- S002
- 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
- 2019-08-19
- Decision date
- 2020-03-11
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for the DS-2 Console. The DS-2 Console uses the same cartridge as the DS-1 Console; however, it has updated hardware and software to accommodate a touchscreen display in addition to modified electrical components to comply with the EU RoHS Standard.
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