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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAIS EXIMER LASER ANGIOPLASTY
Classification Namedevice, angioplasty, laser, coronary
Generic Nameeximer laser for angioplasty w/ model pc4020 cath
ApplicantSPECTRANETICS CORP.
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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