| Gastroenterology-urology devices; classification for external penile rigidity devices. Final rule. | |
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MedLine Citation:
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PMID: 15624252 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 69 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2004 Dec |
Date Detail:
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Created Date: 2004-12-29 Completed Date: 2005-01-17 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: 77621-3 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Equipment Design Equipment Safety / classification Humans Male Penile Prosthesis / classification* United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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