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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.
 
DeviceiDesign Advanced WaveScan Studio, STAR Excimer Laser System
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS062
Date Received10/01/2020
Decision Date02/26/2021
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of several minor clarifications and corrections to either define the original intent of the protocol, or correct mismatched information in the protocol
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