Identity
- Trade Name
- TherOx Downstream System FDA PMA
- Generic Name
- System, oxygen, aqueous FDA PMA
Identifiers
- PMA Number
- P170027 FDA PMA
- FDA Product Code
- MWG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The TherOx Downstream Cartridge is an aqueous oxygen system component designed for the preparation and delivery of SuperSaturated Oxygen Therapy. It is indicated for use in targeted ischemic regions perfused by the left anterior descending coronary artery immediately following percutaneous coronary intervention with stenting.
This device is part of the TherOx Downstream System and is intended for patients treated within 6 hours of the onset of anterior acute myocardial infarction symptoms. The system has received FDA PMA authorization for its specific clinical application. It is manufactured by ZOLL Circulation, Inc. based in San Jose, California.
Frequently asked questions
What is the primary function of the TherOx Downstream Cartridge?
The cartridge is a component of the TherOx Downstream System used to prepare and deliver SuperSaturated Oxygen Therapy to ischemic regions of the heart following a coronary intervention.
Which patients are indicated for treatment with this device?
The device is indicated for patients who have undergone percutaneous coronary intervention with stenting within 6 hours of the onset of anterior acute myocardial infarction symptoms caused by a left anterior descending artery infarct lesion.
Has the TherOx Downstream System received regulatory authorization?
Yes, the system has received FDA PMA authorization, which signifies that the device has undergone a rigorous premarket approval process for its indicated use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170027 | Class III | Active |
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Manufacturer
- Manufacturer
- ZOLL Circulation, Inc.
Sources (1)
- FDA PMA P170027 24 fields · synced Sep 18, 2026