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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.
 
DeviceESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
Generic NameCATHETER, FLOW DIRECTED
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS213
Date Received09/27/2002
Decision Date10/23/2002
Reclassified Date10/08/2010
Product Codes DYG LOX 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  
CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.
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