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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 NumberS008
Date Received05/24/1994
Decision Date07/12/1995
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for upgraded software (version 3. 4) for the spectranetics cvx-300 excimer laser system.
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