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Device | BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P000022 |
Date Received | 05/30/2000 |
Decision Date | 10/16/2000 |
Withdrawal Date
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12/21/2006 |
Product Code |
MAF |
Docket Number | 01M-0039 |
Notice Date | 01/31/2001 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE (OTW) CORONARY STENT DELIVERY SYSTEM AND THE MEDTRONIC AVE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE (RX) CORONARY STENT DELIVERY SYSTEM. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <= 30 MM) IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |