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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
PMA NumberP960010
Date Received05/01/1996
Decision Date06/27/1997
Withdrawal Date 06/09/2008
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 98M-0726
Notice Date 09/09/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic wiktor(r) prime coronary stent delivery 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 graft vessels with reference diameters in the range of 3. 0 to 4. 5 mm.
Supplements: S001 
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