Title 21

SECTION 870.3730

870.3730 Pacemaker service tools.

§ 870.3730 Pacemaker service tools.

(a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001]

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