Identity
- Trade Name
- OLYMPIC COOL-CAP FDA PMA
- Generic Name
- Cap, cooling (infants) FDA PMA
Identifiers
- PMA Number
- P040025 FDA PMA
- FDA Product Code
- MXM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APWD FDA PMA
The Olympic Cool-Cap System is a Cap, cooling (infants) designed to deliver selective head cooling with mild systemic hypothermia. It is intended for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE) to prevent or reduce neurologic injury associated with the condition.
This device is supplied as a reusable system and is regulated under FDA_PMA with approval number P040025. It is classified as a Class III medical device under the MXM product code and is intended for use in neonatal neurology settings. Sterility and specific storage conditions are not detailed in the provided data.
Frequently asked questions
What specific medical condition is the Olympic Cool-Cap System approved to treat in full-term infants?
The Olympic Cool-Cap System is approved for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE), a condition caused by oxygen deprivation to the brain during or around the time of birth. It delivers selective head cooling combined with mild systemic hypothermia to help prevent or reduce neurologic injury linked to HIE.
Is the Olympic Cool-Cap System designed for single-use or reusable applications, and how does this affect its clinical workflow?
The Olympic Cool-Cap System is supplied as a **reusable** device, meaning it can be used multiple times after proper cleaning, maintenance, and reprocessing. This design allows for consistent use across multiple patients in neonatal neurology settings, though facilities must adhere to strict reprocessing protocols to ensure safety and efficacy between uses.
What regulatory pathway was followed for the Olympic Cool-Cap System’s approval, and what does this imply about its oversight?
The Olympic Cool-Cap System underwent **FDA Pre-Market Approval (PMA)** under approval number **P040025**, a rigorous review process for high-risk medical devices. This classification as a **Class III** device under product code **MXM** indicates it is subject to stringent scrutiny due to its critical role in treating neonatal neurologic conditions, ensuring its safety and effectiveness is thoroughly validated.
How is the Olympic Cool-Cap System intended to be used alongside other treatments in neonatal care?
The system is designed to provide **selective head cooling with mild systemic hypothermia** as part of a broader therapeutic approach for infants with moderate to severe HIE. It is not intended as a standalone treatment but rather as an adjunct to standard neonatal care protocols, working in conjunction with monitoring, supportive therapies, and other interventions to mitigate neurologic injury.
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 | P040025 | Class III | Active |
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Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA PMA P040025 24 fields · synced Sep 18, 2026