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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 NameALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantALCON LABORATORIES, INC.
PMA NumberP030008
Supplement NumberS007
Date Received03/12/2012
Decision Date04/11/2012
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a pma supplement for the following three changes from the annual report, 2011: 1) alternate source supplier for ventilator; 2) modified packaging of optical elements: and 3) new supplier for smart cards.
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