| Medical devices; obstetrical and gynecological devices; classification of the hemorrhoid prevention pressure wedge. Final rule. | |
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MedLine Citation:
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PMID: 21513173 Owner: HSR Status: In-Process |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 76 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2011 Apr |
Date Detail:
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Created Date: 2011-04-22 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: 21237-9 Citation Subset: T |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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