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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.
 
DeviceMOBILEXCIMER FOR PTK AND PRK
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
LASER VISION CENTERS, INC.
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
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