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The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

The components of the Miethke Shunt System can include the Paedi-GAV-Valve, a "ballin-cone" valve in line with a gravitational valve. The modified device, is a slightly larger version of the Paedi-GAV-Valve and has slightly higher opening pressures. This modified device will be known as the Gravity Assisted Valve (GAV) and will also be offered as a part of the Miethke Shunt System.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Specifically:

• The section titled "PERFORMANCE DATA" explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system."
• The document primarily focuses on establishing "SUBSTANTIAL EQUIVALENCE" to a previously marketed device, rather than presenting new performance data against specific acceptance criteria. This implies that the regulatory pathway chosen did not require a new study with predefined acceptance criteria for the new device's performance.

Therefore, I cannot populate the requested tables and information as the necessary details are not present in the provided text.

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