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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.
 
DeviceSPECTRANETICS EXCIMER LASER
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
SPECTRANETICS CORP.
9965 federal drive
colorado springs, CO 80921
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 change design/components/specifications/material
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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