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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 Namestent, coronary
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
ApplicantABBOTT VASCULAR INC.
PMA NumberP810046
Supplement NumberS225
Date Received01/14/2008
Decision Date02/08/2008
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in e-beam irradiation equipment.
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