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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAIS EXIMER LASER ANGIOPLASTY
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
SPECTRANETICS CORP.
9965 federal drive
colorado springs, CO 80921
PMA NumberP900032
Date Received05/02/1990
Decision Date01/31/1992
Withdrawal Date 09/13/2011
Product Code
LPC[ Registered Establishments with LPC ]
Docket Number 92M-0078
Notice Date 03/16/1992
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S006 S013 S015 S016 S018 S019 
S020 
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