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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 TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
Classification Namedevice, angioplasty, laser, coronary
Generic Nameexcimer laser
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS012
Date Received11/27/1996
Decision Date09/24/1997
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 2. 0 mm vitesse(tm)-eii (eccentric monorail) catheter, model 120-008.
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