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The iVena Vascular Patch is indicated for use in the repair and closure of the vascular system.

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This document is a 510(k) clearance letter from the FDA for the Atrium Medical iVena Vascular Patch. It does not contain information about acceptance criteria or specific study details proving a device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the provided text. The document is administrative in nature, granting permission to market the device, rather than detailing the technical studies and their outcomes.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the 510(k) submission itself, where such details would typically be found.

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