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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.
DeviceEXCIMER LASER MODEL PC4016(1.3MM),4026(1.6MM)
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
9965 federal drive
colorado springs, CO 80921
PMA NumberP900032
Supplement NumberS006
Date Received02/27/1992
Decision Date08/12/1993
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No