UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Premarket Approval P880081

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

DeviceUV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received1988-11-07
Decision Date1989-10-31
Notice Date1989-11-27
PMAP880081
SupplementS
Product CodeHQL
Docket Number89M-0475
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P880081Original Filing
S047 2022-11-09 30-day Notice
S046 2020-12-10 30-day Notice
S045
S044
S043 2019-05-28 Special (immediate Track)
S042 2019-03-08 Special (immediate Track)
S041 2018-04-11 30-day Notice
S040 2016-06-02 30-day Notice
S039 2015-04-01 30-day Notice
S038 2012-12-31 30-day Notice
S037 2011-11-14 135 Review Track For 30-day Notice
S036 2008-01-28 30-day Notice
S035 2007-10-02 30-day Notice
S034 2007-09-24 30-day Notice
S033 2007-05-07 30-day Notice
S032 2006-05-30 Real-time Process
S031 2005-06-28 30-day Notice
S030 2005-01-03 Real-time Process
S029 2003-08-06 Special (immediate Track)
S028
S027 2001-11-19 Normal 180 Day Track
S026 2000-06-23 Normal 180 Day Track
S025
S024 1999-01-07 Normal 180 Day Track
S023 1997-06-30 Real-time Process
S022 1996-09-27 Normal 180 Day Track
S021
S020 1995-11-13 Normal 180 Day Track
S019 1995-11-03 Normal 180 Day Track
S018 1995-04-04 Normal 180 Day Track
S017 1993-08-03 Normal 180 Day Track
S016
S015
S014 1992-07-21 Normal 180 Day Track
S013 1992-06-30 Normal 180 Day Track
S012 1992-03-17 Normal 180 Day Track
S011 1992-02-04 Normal 180 Day Track
S010
S009 1991-01-25 Normal 180 Day Track
S008
S007 1990-08-02 Normal 180 Day Track
S006 1989-12-27 Normal 180 Day Track
S005 1990-02-28 Normal 180 Day Track
S004 1990-02-07 Normal 180 Day Track
S003 1989-12-15 Normal 180 Day Track
S002 1989-12-13 Normal 180 Day Track
S001 1989-08-25 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.