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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.
 
DeviceIC-8 Apthera Intraocular Lens (IOL)
Generic NameExtended depth of focus intraocular lens
Regulation Number886.3600
ApplicantAcu Focus, Inc.
32 Discovery Suite 200
Irvine, CA 92618
PMA NumberP210005
Supplement NumberS004
Date Received11/04/2022
Decision Date12/02/2022
Product Code POE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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