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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 RX CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
Regulation Number870.5100
ApplicantGUIDANT CORP.
PMA NumberP810046
Supplement NumberS216
Date Received03/08/2004
Decision Date06/18/2004
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for the voyager rx coronary dilatation catheter. The device, as modified, is indicated for 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 2) balloon dilatation of a coronary occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, and 3) balloon dilatation of stent after implantation (testing including the following guidant stents: multi-link: pixel and penta and zeta coronary stent systems).
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