(31 days)
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).
Not Found
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.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.