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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBX VELOCITY(TM) STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantCORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-5700
PMA NumberP900043
Supplement NumberS025
Date Received07/10/2000
Decision Date02/02/2001
Withdrawal Date 09/02/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW INDICATION (I.E., DE NOVO AND RESTENOTIC LESIONS) AND ADDITIONAL STENT DIAMETERS (I.E., 4.5 AND 5.0 MM) FOR THE BX VELOCITY(TM) STENT WITH RAPTOR(TM) OVER-THE-WIRE DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS (<=30 MM INLENGTH) IN NATIVE CORONARY ARTERIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 MM TO 5.0 MM; AND 2) FOR TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 MM TO 4.00 MM. THE 2.25 MM, 2.5 MM, AND 2.75 MM DIAMETERS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED CLOSURE, AND THE 4.5 AND 5.0 MM DIAMETERS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS.
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