Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

Agency Contact: Melissa Burns, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616.