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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.
 
DeviceNC STORMER MX2/OTW BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP790017
Supplement NumberS082
Date Received04/05/2004
Decision Date03/04/2005
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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