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. |
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Device | HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P900043 |
Supplement Number | S031 |
Date Received | 12/21/2001 |
Decision Date | 05/10/2002 |
Withdrawal Date
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09/02/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, IS 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 IN LENGTH) 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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