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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.
 
Trade NameNC STORMER MX2/OTW BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC VASCULAR GALWAY LIMITED
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 design change - minor
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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