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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 NumberS230
Date Received04/01/2009
Decision Date07/15/2009
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the protective balloon sheath. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction; and 3) balloon dilation of a stent after implantation.
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