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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.
 
DeviceNC STORMER MX2/OTW BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS082
Date Received04/05/2004
Decision Date03/04/2005
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION OF THE NC STORMER MX2 CATHETER WITH TWO ADDITIONAL LENGTHS (AS A MODIFIED VERSION OF THE APPROVED NC STORMER MX CATHETER) AND THE ADDITION OF TWO ADDITIONAL LENGTHS FOR THE NC STORMER OTW CATHETER.
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