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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-C OS CATHETER MODELS 114-009, 117-016, AND 120-009
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS014
Date Received08/25/1998
Decision Date01/28/2000
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 is for the Vitesse-C OS Laser Angioplasty Cathethers, Models 114-009, 117-016, and 120-009.
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