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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.
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
PMA NumberP030008
Supplement NumberS008
Date Received07/30/2012
Decision Date09/07/2012
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for introduction of a new notebook computer model (toshiba tecra a11) to replace the current notebook model (toshiba tecra m10) which is being phased out by the manufacturer. This will require a change in the operating system from windows 2000 to windows xp service pack 2 as the new notebook computer will not be supported by the old system.