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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.
 
DeviceVISX STAR S2 AND S3 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAmo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS010
Date Received06/18/1999
Decision Date10/18/2000
Product Code LZS 
Docket Number 01M-0015
Notice Date 01/22/2001
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THESE DEVICES ARE INDICATED FOR PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENTS: IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D PER YEAR FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF PRE-OPERATIVE EXAMINATION; ANDIN PATIENTS 21 YEARS OF AGE OR OLDER FOR THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING HYPEROPIA BETWEEN +0.5 AND + 5.0 D SPHERE AT THE SPECTACLE PLANE WITH REFRACTIVE ASTIGMATISM FROM +0.5 TO +4.0 D WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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