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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.
 
DeviceS540 OVER THE WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP970035
Supplement NumberS018
Date Received12/03/1999
Decision Date12/22/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing changes being made to the inner member necking process.
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