Document Detail

Cardiovascular devices; reclassification of certain percutaneous transluminal coronary angioplasty (PTCA) catheters. Final rule.
MedLine Citation:
PMID:  20824947     Owner:  HSR     Status:  MEDLINE    
The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device type.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  75     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-08     Completed Date:  2010-10-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  54493-6     Citation Subset:  T    
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary / classification*,  instrumentation
Catheterization / classification*,  instrumentation
Device Approval / legislation & jurisprudence*
Equipment Safety / classification*
United States
United States Food and Drug Administration

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