ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES

Intraocular Lens

FDA Premarket Approval P840039

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received1984-08-27
Decision Date1986-03-28
Notice Date1986-07-01
PMAP840039
SupplementS
Product CodeHQL
Docket Number86M-0169
Advisory CommitteeOphthalmic
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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