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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 NameVOYAGER NC CORONARY DILATATION CATHETER
Classification Namestent, coronary
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
ApplicantABBOTT VASCULAR INC.
PMA NumberP810046
Supplement NumberS226
Date Received02/13/2008
Decision Date08/21/2008
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the voyager nc coronary dilatation catheter. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis of the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction; 3) balloon dilatation of a stent after implantation.
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