(86 days)
The iVena Vascular Patch is indicated for use in the repair and closure of the vascular system.
Not Found
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.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).