Document Detail


Gastroenterology-urology devices; classification for external penile rigidity devices. Final rule.
MedLine Citation:
PMID:  15624252     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  69     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-12-29     Completed Date:  2005-01-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  77621-3     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
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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