IC-8 Apthera Intraocular Lens (IOL)

FDA Premarket Approval P210005 S002

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.

Pre-market Approval Supplement Details

DeviceIC-8 Apthera Intraocular Lens (IOL)
Generic NameExtended Depth Of Focus Intraocular Lens
ApplicantAcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS002 Date Received08/23/2022 Decision Date09/20/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-08-23
Decision Date2022-09-20
PMAP210005
SupplementS002
Product CodePOE 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressAcuFocus, Inc.
32 Discovery
suite 200
irvine, CA 92618 PMA NumberP210005 Supplement NumberS002 Date Received08/23/2022 Decision Date09/20/2022 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 Approval Order Statement  
approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210005.

Supplemental Filings

Supplement NumberDateSupplement Type
P210005Original Filing
S004 2022-11-04 Normal 180 Day Track No User Fee
S003
S002 2022-08-23 Normal 180 Day Track No User Fee
S001 2022-08-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

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