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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
Generic Namelens, intraocular, phakic
Applicant
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS039
Date Received06/27/2019
Decision Date07/26/2019
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices.
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