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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.
 
DeviceS670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS039
Date Received04/24/2002
Decision Date04/17/2003
Withdrawal Date10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE LABELING OF THE S670 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS TO INCLUDE POST-PROCEDURE RESULTS FOR THE PREDICT STUDY POPULATION AND REMOVE REFERENCES TO THE EUROPEAN RACECAR STUDY.
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