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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.
 
DeviceVISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP030016
Supplement NumberS028
Date Received10/19/2015
Decision Date11/17/2015
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
THE REPLACEMENT OF AN INSTRUMENT TO MEASURE DIOPTRIC POWER AND IMAGE QUALITY (MTF) AT FINAL PRODUCT INSPECTION.
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