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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVOYAGER RX CORONARY DILATATION CATHETER
Generic NameSTENT, CORONARY
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS223
Date Received08/20/2007
Decision Date09/19/2007
Reclassified Date10/08/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFICATION OF THE CUTTING PROCESS FOR NECKED TUNGSTEN TUBING FROM A MANUAL TO AN AUTOMATED PROCESS.
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