Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products

Aid, Surgical, Viscoelastic

FDA Premarket Approval P810031 S062

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

Change in the composition of the coating used inside the dissolution chambers.

DeviceHealon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
Classification NameAid, Surgical, Viscoelastic
Generic NameAid, Surgical, Viscoelastic
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2017-06-26
Decision Date2017-07-20
PMAP810031
SupplementS062
Product CodeLZP
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
P810031Original Filing
S072 2021-06-02 30-day Notice
S071
S070
S069 2020-11-27 30-day Notice
S068 2020-10-01 30-day Notice
S067 2020-04-29 30-day Notice
S066
S065 2018-12-03 Normal 180 Day Track
S064 2018-02-02 30-day Notice
S063 2017-10-30 Normal 180 Day Track
S062 2017-06-26 30-day Notice
S061 2016-11-16 30-day Notice
S060
S059 2016-11-14 Normal 180 Day Track No User Fee
S058 2016-08-01 Real-time Process
S057 2016-06-10 30-day Notice
S056 2015-12-17 Normal 180 Day Track
S055 2015-11-25 Special (immediate Track)
S054 2015-06-11 Normal 180 Day Track
S053 2015-06-03 30-day Notice
S052 2015-02-18 30-day Notice
S051 2014-08-29 30-day Notice
S050 2013-07-19 30-day Notice
S049 2013-07-01 30-day Notice
S048 2013-05-28 30-day Notice
S047 2013-03-15 30-day Notice
S046 2012-10-22 Real-time Process
S045 2012-07-02 30-day Notice
S044 2012-03-30 30-day Notice
S043 2012-01-17 30-day Notice
S042 2012-01-04 30-day Notice
S041 2011-10-07 30-day Notice
S040 2011-08-01 30-day Notice
S039 2011-06-23 30-day Notice
S038 2010-09-03 Normal 180 Day Track No User Fee
S037 2010-04-13 Real-time Process
S036 2008-08-20 30-day Notice
S035 2008-01-18 Normal 180 Day Track No User Fee
S034 2007-05-07 30-day Notice
S033 2006-12-11 135 Review Track For 30-day Notice
S032 2006-11-01 30-day Notice
S031 2006-09-29 Normal 180 Day Track No User Fee
S030 2006-08-14 30-day Notice
S029 2006-08-14 30-day Notice
S028 2006-08-14 30-day Notice
S027 2006-04-13 Real-time Process
S026 2005-02-08 30-day Notice
S025 2003-11-14 30-day Notice
S024 2002-07-10 Special (immediate Track)
S023 2000-05-12 Normal 180 Day Track
S022 1999-09-20 Normal 180 Day Track
S021
S020
S019 1994-10-07 Normal 180 Day Track
S018 1994-10-03 Normal 180 Day Track
S017 1994-02-23 Normal 180 Day Track
S016
S015
S014 1990-07-05 Normal 180 Day Track
S013 1989-04-24 Normal 180 Day Track
S012 1988-11-22 Normal 180 Day Track
S011 1988-06-01 Normal 180 Day Track
S010 1987-08-13 Normal 180 Day Track
S009
S008 1986-06-03 Normal 180 Day Track
S007 1985-11-07
S006 1984-09-17
S005 1984-02-23
S004 1984-02-10
S003
S002 1984-01-27
S001 1983-08-31

NIH GUDID Devices

Device IDPMASupp
05050474651425 P810031 063
05050474636996 P810031 063
05050474636989 P810031 063
05050474636972 P810031 063
05050474651654 P810031 065

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