federal_register: 2012-15244

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-15244 Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator Rule 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. 2012-06-22 2012 6 https://www.federalregister.gov/documents/2012/06/22/2012-15244/effective-date-of-requirement-for-premarket-approval-for-an-implantable-pacemaker-pulse-generator https://www.govinfo.gov/content/pkg/FR-2012-06-22/pdf/2012-15244.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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