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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.
 
DeviceCOLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL
Generic Namelens, intraocular, phakic
Applicant
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS025
Date Received03/12/2013
Decision Date08/22/2013
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT STAAR SURGICAL COMPANY IN MONROVIA, CALIFORNIA.
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