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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMOBILEXCIMER FOR PTK AND PRK
Generic NameExcimer laser system
ApplicantLASER VISION CENTERS, INC.
540 MARYVILLE CENTRE DR., #200
ST. LOUIS, MO 63141
PMA NumberP960019
Supplement NumberS001
Date Received11/22/1996
Decision Date04/07/1997
Withdrawal Date 02/26/2002
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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