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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 Namestent, coronary
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
PMA NumberP810046
Supplement NumberS228
Date Received03/09/2009
Decision Date04/06/2009
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to re-establish the temecula, california manufacturing site for the device.
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