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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.
 
DeviceELCA CORONARY ATHERECTOMY CATHETERS
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSpectranetics Corp.
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS047
Date Received05/09/2011
Decision Date01/13/2012
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.
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