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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
PMA NumberP960010
Supplement NumberS001
Date Received11/25/1997
Decision Date05/21/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic model 6322 wiktor(r) rival(tm) coronary stent system. This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3. 0 to 4. 5mm.
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