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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.
 
DeviceS7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS027
Date Received05/11/2001
Decision Date05/29/2001
Withdrawal Date10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE LENGTH AND INNER DIAMETER OF THE THIRD AND FOURTH TFE BAKING SHEATHS IN SIZE TO FACILITATE THEIR APPLICATION DURING THE STENT/BALLOON BAKING PROCESS.
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