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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) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, FL 33014-5700
PMA NumberP900043
Supplement NumberS024
Date Received02/08/2000
Decision Date07/21/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A HEPARIN COATING TO THE BX VELOCITY(TM) CORONARY STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR(TM) STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE 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 TO 4.00 MM.
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