TherOx Downstream Cartridge
FDA premarket approval P170027/S019 · decided 2025-06-20
Approval details
- PMA number
- P170027
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx Downstream Cartridge
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2025-05-21
- Decision date
- 2025-06-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- to change the manufacturing location for the capillary component of the TherOx DownStream Cartridge
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