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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.
 
Trade NameSVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
Classification Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS012
Date Received07/14/1998
Decision Date10/21/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-0424
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the svs apex plus excimer laser workstation, emphasis(r) discs k and l, and axicon. These devices are indicated to perform hyperopic prk.
Approval Order Approval Order
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