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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 NameSPECTRANETICS EXCIMER LASER
Classification Namedevice, angioplasty, laser, coronary
Generic Namecoronary angioplasty catheter
ApplicantSPECTRANETICS CORP.
PMA NumberP910001
Supplement NumberS056
Date Received05/08/2012
Decision Date07/03/2012
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the radio frequency (rf) absorption material for the cvx-300p model excimer laser.
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