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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 217A EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser
ApplicantALLIANCE MEDICAL PRODUCTS, INC.
PMA NumberP990027
Supplement NumberS001
Date Received10/13/2000
Decision Date12/22/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at technolas gmbh, kircheim/heimstetten, germany.
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