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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.
 
DeviceCVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS025
Date Received04/14/2006
Decision Date08/02/2006
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.
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