| Effective date of requirement for premarket approval for a pacemaker programmer. Final rule. | |
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MedLine Citation:
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PMID: 22730574 Owner: HSR Status: In-Process |
Abstract/OtherAbstract:
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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 pacemaker programmers. 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. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 77 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2012 Jun |
Date Detail:
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Created Date: 2012-06-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 37570-3 Citation Subset: T |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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