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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 NameTECHNOLAS(R)217A OPHTHALMIC EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP990027
Supplement NumberS003
Date Received04/27/2001
Decision Date09/25/2001
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add an active eyetracker as an accessory to the laser system.
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