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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.
 
DeviceLASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Generic NameExcimer laser system
ApplicantLaser Vision Centers, Inc.
540 Maryville Centre Dr., #200
St. Louis, MO 63141
PMA NumberP960019
Supplement NumberS002
Date Received04/17/1998
Decision Date05/05/1998
Withdrawal Date02/26/2002
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK. The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.
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