enVista Hydrophobic Arcylic Intraocular Lens

Intraocular Lens

FDA Premarket Approval P910056 S031

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

Modification of the lens holder internal surface finish for the envista one piece hydrophobic acrylic intraocular lens, models mx60 and mx60t.

DeviceenVista Hydrophobic Arcylic Intraocular Lens
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2018-07-06
Decision Date2018-08-06
PMAP910056
SupplementS031
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
P910056Original Filing
S049 2021-12-22 30-day Notice
S048 2021-09-22 30-day Notice
S047
S046 2021-06-22 30-day Notice
S045
S044 2020-12-04 30-day Notice
S043 2020-02-19 Normal 180 Day Track
S042
S041 2019-12-23 30-day Notice
S040 2019-12-20 30-day Notice
S039
S038 2019-07-03 30-day Notice
S037
S036 2019-04-03 Normal 180 Day Track
S035 2018-10-16 30-day Notice
S034 2018-10-02 30-day Notice
S033
S032
S031 2018-07-06 30-day Notice
S030 2018-06-11 30-day Notice
S029 2017-12-15 30-day Notice
S028 2017-11-08 30-day Notice
S027 2017-10-30 Panel Track
S026 2017-10-02 30-day Notice
S025
S024 2016-10-21 Normal 180 Day Track
S023 2016-06-03 30-day Notice
S022 2016-05-03 30-day Notice
S021 2015-11-06 30-day Notice
S020 2015-03-30 30-day Notice
S019 2015-03-25 135 Review Track For 30-day Notice
S018 2014-08-11 30-day Notice
S017 2014-05-05 Normal 180 Day Track
S016 2014-03-27 30-day Notice
S015 2013-12-05 30-day Notice
S014 2013-01-28 135 Review Track For 30-day Notice
S013 2012-09-07 Real-time Process
S012 2012-08-06 30-day Notice
S011 2012-07-23 Real-time Process
S010 2011-09-12 Normal 180 Day Track
S009
S008 2003-06-11 Real-time Process
S007 1999-11-24 Real-time Process
S006 1997-03-06 Normal 180 Day Track
S005
S004
S003 1992-06-16 Normal 180 Day Track
S002 1992-04-28 Normal 180 Day Track
S001 1991-11-06 Normal 180 Day Track

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