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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.
 
DeviceMEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronics Interventional Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP960010
Supplement NumberS001
Date Received11/25/1997
Decision Date05/21/1998
Withdrawal Date06/09/2008
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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