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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 NameSPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Classification Namedevice, angioplasty, laser, coronary
Generic Nameexcimer laser
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS005
Date Received06/17/1993
Decision Date07/31/1995
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 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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