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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 NameSPRINTER MX2 BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC VASCULAR
PMA NumberP790017
Supplement NumberS083
Date Received12/10/2004
Decision Date06/22/2005
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a new catheter to the approved product line. The device, as modified, will be marketed under the trade name sprinter mx2 and is indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The 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 sprinter balloon dilatation catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers? stents due to differences i stent design.
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