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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 LEGEND RX BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
PMA NumberP790017
Supplement NumberS096
Date Received03/31/2008
Decision Date10/31/2008
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sprinter legend rapid exchange balloon dilatation catheter. The device, as modified, is indicated for balloon dilatation of 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. 25 mm ¿ 4. 0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
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