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For reconstruction and repair of the pericardium

Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of

The provided document is a 510(k) Premarket Notification for the PRECLUDE® Pericardial Membrane. It details a modification to the labeling only of an already marketed device. Therefore, the information provided does not contain a study proving the device meets acceptance criteria as this submission is not introducing a new device or a change in technological characteristics. Instead, it relies on the substantial equivalence to its predicate device.

Here's an analysis based on the understanding that this is a labeling modification submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission is a modification to labeling only, there are no new acceptance criteria or reported device performance metrics established for this specific submission. The device's performance relies on the previous clearance of the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance:

No new test set was used for this submission. The efficacy and safety of the ePTFE material were previously established and are referenced as: "Reports of data from animal studies and from clinical experiences documented in the literature demonstrate that ePTFE material with a nominal pore size of

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