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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.
 
DeviceCORONARY DILATATION CATHETERS
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 ynez rd.
temecula, CA 92591
PMA NumberP810046
Supplement NumberS220
Date Received11/06/2006
Decision Date12/11/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization site located at sterigenics, santa teresa, new mexico.
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