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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 NameVISX MODELB/MODEL C EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameeximer laser
ApplicantAMO MANUFACTURING USA, LLC
PMA NumberP910062
Date Received10/16/1991
Decision Date09/29/1995
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 96M-0486
Notice Date 12/23/1996
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for visx excimer laser system (models b & c).
Supplements: S001 S004 S006 
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