Document Detail

Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule.
MedLine Citation:
PMID:  11067714     Owner:  NLM     Status:  MEDLINE    
The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  65     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2000 Aug 
Date Detail:
Created Date:  2000-10-26     Completed Date:  2000-10-26     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  48609-12     Citation Subset:  T    
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MeSH Terms
Device Approval*
Equipment Design
Equipment Safety
Gastroenterology / classification,  instrumentation*
Lithotripsy / classification,  instrumentation*
United States
United States Food and Drug Administration
Urology / classification,  instrumentation*

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