TherOx Downstream System
FDA premarket approval P170027/S008 · decided 2023-03-09
Approval details
- PMA number
- P170027
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2021-11-05
- Decision date
- 2023-03-09
- Days to decision
- 489 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval of the refurbishment process for DS-2 Consoles meant to be used in the TherOx DownStream System
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