TherOx Downstream Console
FDA premarket approval P170027/S010 · decided 2022-10-27
Approval details
- PMA number
- P170027
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx Downstream Console
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2022-09-30
- Decision date
- 2022-10-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Supplier change of the TherOx® DownStream® Console Model DS-2 sub-assemblies due to impacts from COVID-19 pandemic.
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