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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.
 
DeviceDRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP030009
Supplement NumberS004
Date Received11/30/2005
Decision Date12/22/2005
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 
Change in an approved supplier's processing steps to allow them to further process a subassembly in accordance with your own manufacturing operations and device specifications.
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