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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.
 
DeviceDRIVER AND MICRODRIVER CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP030009
Supplement NumberS028
Date Received11/05/2008
Decision Date12/24/2008
Withdrawal Date04/02/2026
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
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