These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Effective date of requirement for premarket approval for an implantable pacemaker pulse generator. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2012 Jun 22; 77(121):37575-6. PubMed ID: 22730575.
    Abstract:
    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.
    [Abstract] [Full Text] [Related] [New Search]