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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 (ICL)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS041
Date Received06/22/2021
Decision Date07/19/2021
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Adding an alternative facility for water and pre-sterile product bioburden testing.
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