TherOx Downstream System
FDA premarket approval P170027/S017 · decided 2024-12-19
Approval details
- PMA number
- P170027
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TherOx Downstream System
- Generic name
- System, oxygen, aqueous
- Applicant
- Zoll Circulation, Inc.
- Date received
- 2024-11-25
- Decision date
- 2024-12-19
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MWG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- Approval for additional inspection step in the manufacturing process approval for the Cartridge Chambers and Cartridge Oxygen Port Filter.
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