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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.
 
DeviceMICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS009
Date Received10/21/1998
Decision Date11/17/1998
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The 30-day Notice requested a change int he current Thermal Transfer Printing on the Strain Relief to Ink Jet Printing on the Proximal Two-arm Luer Adapter.
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