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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 NameSUMMIT AUTONOMOUS LADARVISION 4000 SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantSUMMAUTO
PMA NumberP970043
Supplement NumberS008
Date Received05/05/2000
Decision Date07/11/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the corresponding company name change, device name change, and some external changes to the device. The device, as modified, will be marketed under the trade name summit autonomous ladarvision 4000 laser system.
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