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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 OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC VASCULAR
PMA NumberP790017
Supplement NumberS079
Date Received01/16/2003
Decision Date03/04/2003
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 to make modifications to the stormer balloon dilatation catheter with zipper delivery. The devices, as modified, will be marketed under the trade names nc stormer over-the-wire balloon dilatation catheter and nc stormer zipper mx balloon dilatation catheter and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The nc stormer balloon dilatation catheter (balloon models 2. 5 mm - 4. 0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. Note: bench testing was conducted with the nc stormer balloon dilatation catheter and marketed balloon expandable stents. Consideration would be taken when the device is used with different manufacturers' stents due to differences in stent design.
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