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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 NameDURA STAR RX PTCA BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS089
Date Received12/21/2006
Decision Date08/29/2007
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 a new catheter model. The device, as modified, will be marketed under the trade name dura star rx ptca balloon dilatation catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. In addition, the dura star rx ptca dilatation catheter is indicated for post-delivery expansion of balloon expandable stents.
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