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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.
 
DeviceSPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS005
Date Received06/17/1993
Decision Date07/31/1995
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR VITESSE-E (MODEL 117-005) & VITESSE-E II (MODEL 117-205) CATHETERS TO BE USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS MEETING ONE OR MORE OF YOUR APPROVED INDICATIONS FOR USE
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