Document Detail


Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.
MedLine Citation:
PMID:  10177327     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Jan 
Date Detail:
Created Date:  1998-04-21     Completed Date:  1998-04-21     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  4457     Citation Subset:  H    
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MeSH Terms
Descriptor/Qualifier:
Device Approval / legislation & jurisprudence*
Equipment Safety
Humans
Implants, Experimental / standards*
Transcutaneous Electric Nerve Stimulation / standards*
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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