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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Trade NameVITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009
Classification Namedevice, angioplasty, laser, coronary
Generic Nameexcimer laser
PMA NumberP910001
Supplement NumberS014
Date Received08/25/1998
Decision Date01/28/2000
Product Code
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for the vitesse-c os laser angioplasty cathethers, models 114-009, 117-016, and 120-009.