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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.
 
DeviceVITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS018
Date Received02/09/2000
Decision Date08/04/2000
Product Code LPC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER, MODEL 110-003.
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