enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)

FDA Premarket Approval P910061 S026

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

A new process for electroplating molds for intraocular lens models li61se and li61ao

DeviceenVista One-Piece Foldable Acrylic Intraocular Lens (IOL)
Generic NameIntraocular Lens
ApplicantBAUSCH & LOMB
Date Received2020-12-11
Decision Date2021-01-04
PMAP910061
SupplementS026
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BAUSCH & LOMB 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P910061Original Filing
S026 2020-12-11 30-day Notice
S025 2019-01-04 30-day Notice
S024
S023 2016-05-31 30-day Notice
S022 2015-10-15 30-day Notice
S021
S020 2013-07-31 30-day Notice
S019 2009-11-02 30-day Notice
S018 2009-06-09 30-day Notice
S017 2008-06-19 30-day Notice
S016 2008-04-03 30-day Notice
S015 2006-08-30 Real-time Process
S014 2006-04-03 Real-time Process
S013 2006-03-30 Real-time Process
S012 2004-03-29 Normal 180 Day Track No User Fee
S011 2004-03-18 Real-time Process
S010 2003-06-23 30-day Notice
S009 2003-06-11 Real-time Process
S008 1999-02-10 Real-time Process
S007 1998-12-18 Normal 180 Day Track
S006 1998-12-01 Real-time Process
S005 1998-10-29 135 Review Track For 30-day Notice
S004 1998-09-18 Real-time Process
S003 1998-08-07 Normal 180 Day Track
S002
S001 1997-06-10 Normal 180 Day Track

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.