Akreos One-Piece Foldable Acrylic Intraocular Lens

FDA Premarket Approval P060022 S028

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

Transfer of the bioburden and endotoxin testing methods from nelson laboratories inc. To in-house at the b+l clearwater, fl facility

DeviceAkreos One-Piece Foldable Acrylic Intraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2020-12-04
Decision Date2020-12-21
PMAP060022
SupplementS028
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P060022Original Filing
S028 2020-12-04 30-day Notice
S027
S026
S025 2019-12-23 30-day Notice
S024 2018-07-10 30-day Notice
S023 2016-06-03 30-day Notice
S022 2015-09-11 135 Review Track For 30-day Notice
S021 2015-02-18 30-day Notice
S020 2014-12-08 Real-time Process
S019 2014-05-15 30-day Notice
S018
S017 2013-06-10 30-day Notice
S016 2013-04-15 Real-time Process
S015 2013-02-22 30-day Notice
S014 2012-08-20 30-day Notice
S013 2012-03-20 Real-time Process
S012 2011-06-21 Normal 180 Day Track
S011 2011-05-09 30-day Notice
S010 2011-02-16 Normal 180 Day Track No User Fee
S009 2011-03-18 30-day Notice
S008 2011-03-18 135 Review Track For 30-day Notice
S007 2010-04-30 30-day Notice
S006 2010-01-29 Real-time Process
S005 2009-08-25 30-day Notice
S004 2009-03-06 30-day Notice
S003
S002 2008-10-24 Real-time Process
S001 2008-10-20 30-day Notice

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