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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 Toric ICL (Implantable Collamer Lens)
Generic Namelens, intraocular, phakic
Applicant
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS038
Date Received05/21/2019
Decision Date07/19/2019
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol for the post-approval study (PAS) protocol.
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