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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 CORONARY ANGIOPLASTY (ELCA) SYSTEM
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS020
Date Received03/30/2001
Decision Date10/10/2001
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM. THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER.
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