Document Detail

Development of PMA guidance for ventricular assist devices and total artificial heart.
MedLine Citation:
PMID:  18244064     Owner:  NLM     Status:  In-Data-Review    
The US Food and Drug Administration's (FDA's) involvement in the investigation of devices since 1980 is discussed. The development of draft guidelines for a premarket approval application (PMA) is described. The availability of the document is announced and comments are solicited.
A Acharya
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  IEEE engineering in medicine and biology magazine : the quarterly magazine of the Engineering in Medicine & Biology Society     Volume:  7     ISSN:  0739-5175     ISO Abbreviation:  IEEE Eng Med Biol Mag     Publication Date:  1988  
Date Detail:
Created Date:  2008-02-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8305985     Medline TA:  IEEE Eng Med Biol Mag     Country:  United States    
Other Details:
Languages:  eng     Pagination:  90-1     Citation Subset:  -    
Food and Drug Adm., Silver Spring, MD.
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