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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 Nameexcimer laser system
540 maryville centre dr., #200
st. louis, MO 63141
PMA NumberP960019
Supplement NumberS001
Date Received11/22/1996
Decision Date04/07/1997
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the laservision(r)/visx excimer laser system model c for ptk and prk to be installed in the calumet coach model mmt-436v semi-trailer coach, which will be manufactured by the calumet coach company, 2150 e. Dalton rd. , calumet city, il 60409-1411. The device, as modified, will be marketed under the trade name mobilexcimer(r) for phototherapeutic keratectomy (ptk) and photorefractive keratectomy (prk) the device indications remained the same.