TherOx Downstream System
FDA premarket approval P170027/S005 · decided 2021-06-01
Approval details
- PMA number
- P170027
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2021-03-23
- Decision date
- 2021-06-01
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for a manufacturing site located at ZOLL Circulation Facility (2000 Ringwood Ave, San Jose, CA, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the TherOx® DownStream® System Console only.
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