Sodium Hyaluronate Ophtalmic Viscoelastic s (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack

FDA Premarket Approval P810031 S067

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

Removal of an in-process raw material quality control test affecting the sodium hyaluronate (nahy) raw material for the healon endocoat® ophthalmic viscosurgicaldevice (ovd)

DeviceSodium Hyaluronate Ophtalmic Viscoelastic s (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack
Generic NameAid, Surgical, Viscoelastic
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-04-29
Decision Date2020-05-11
PMAP810031
SupplementS067
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
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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