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Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle. The permanent pacing lead, Model PY2, is used in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker).

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This document is a 510(k) clearance letter from the FDA for a medical device called "Permanent Pacing Lead, Model PY2." It's a regulatory document and does not contain information about acceptance criteria or a study proving the device meets them in the format requested. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. This kind of detail would typically be found in the manufacturer's 510(k) submission itself, or in a separate clinical study report, which is not provided here.

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