enVista One-Piece Foldable Acrylic Intraocular Lens

FDA Premarket Approval P910056 S044

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

DeviceenVista One-Piece Foldable Acrylic Intraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2020-12-04
Decision Date2020-12-21
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
S044 2020-12-04 30-day Notice
S043 2020-02-19 Normal 180 Day Track
S041 2019-12-23 30-day Notice
S040 2019-12-20 30-day Notice
S038 2019-07-03 30-day Notice
S036 2019-04-03 Normal 180 Day Track
S035 2018-10-16 30-day Notice
S034 2018-10-02 30-day Notice
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
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
S008 2003-06-11 Real-time Process
S007 1999-11-24 Real-time Process
S006 1997-03-06 Normal 180 Day Track
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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