Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode
Information
Type
Rule
Regulated products
Published
July 6, 2012
Last updated
July 6, 2012
Description
Document number 2012-16486. 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 the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)