EZE-FIT(TM)

Intraocular Lens

FDA Premarket Approval P840039 S048

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

Approval for the trade name eze-fit for your one-piece polymethylmethacrylate intraocular lenses

DeviceEZE-FIT(TM)
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received1995-10-10
Decision Date1996-07-18
PMAP840039
SupplementS048
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P840039Original Filing
S064 2022-07-11 30-day Notice
S063 2019-01-04 30-day Notice
S062 2017-06-15 30-day Notice
S061 2016-05-17 30-day Notice
S060
S059 2009-11-02 30-day Notice
S058 2009-06-19 30-day Notice
S057 2008-06-19 30-day Notice
S056 2008-04-03 30-day Notice
S055 2005-11-22 Real-time Process
S054 2004-03-29 Normal 180 Day Track No User Fee
S053 2004-03-18 Real-time Process
S052 2003-06-23 30-day Notice
S051 2003-06-11 Real-time Process
S050 2002-04-08 Normal 180 Day Track
S049 1995-12-19 Normal 180 Day Track
S048 1995-10-10 Normal 180 Day Track
S047 1994-11-21 Normal 180 Day Track
S046 1994-06-02 Normal 180 Day Track
S045 1993-10-05 Normal 180 Day Track
S044 1993-08-18 Normal 180 Day Track
S043 1993-04-02 Normal 180 Day Track
S042 1993-02-16 Normal 180 Day Track
S041 1992-09-14 Normal 180 Day Track
S040 1992-09-04 Normal 180 Day Track
S039 1992-08-27 Normal 180 Day Track
S038 1992-08-27 Normal 180 Day Track
S037 1992-05-15 Normal 180 Day Track
S036 1992-03-03 Normal 180 Day Track
S035 1992-01-29 Normal 180 Day Track
S034 1992-01-17 Normal 180 Day Track
S033
S032 1991-10-08 Normal 180 Day Track
S031 1991-08-19 Normal 180 Day Track
S030 1991-08-19 Normal 180 Day Track
S029 1990-03-30 Normal 180 Day Track
S028 1990-02-02 Normal 180 Day Track
S027
S026
S025
S024
S023
S022 1988-12-12 Normal 180 Day Track
S021 1988-12-08 Normal 180 Day Track
S020
S019
S018 1988-11-25 Normal 180 Day Track
S017
S016
S015 1988-11-25 Normal 180 Day Track
S014
S013 1988-11-25 Normal 180 Day Track
S012 1988-11-18 Normal 180 Day Track
S011
S010
S009
S008
S007 1988-09-30 Normal 180 Day Track
S006 1988-08-01 Panel Track
S005
S004
S003 1987-07-30 Normal 180 Day Track
S002 1987-03-16 Normal 180 Day Track
S001

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