HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)

FDA Premarket Approval P110007

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

Approval for the healon endocoat ovd. Healon endocoat ovd is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment surgical procedures including, cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, and secondary intraocular lens implantation. Healon endocoat ovd maintains a deep chamber during anterior segment surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

DeviceHEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
Generic NameAid, Surgical, Viscoelastic
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2011-02-22
Decision Date2012-07-02
Notice Date2012-07-16
PMAP110007
SupplementS
Product CodeLZP 
Docket Number12M-0734
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P110007Original Filing
S013 2020-10-01 30-day Notice
S012 2020-04-29 30-day Notice
S011 2016-11-16 30-day Notice
S010
S009 2016-11-14 Normal 180 Day Track No User Fee
S008 2016-08-01 Real-time Process
S007 2015-11-25 Special (immediate Track)
S006 2015-02-18 30-day Notice
S005 2013-05-28 30-day Notice
S004 2013-04-01 30-day Notice
S003 2013-04-01 135 Review Track For 30-day Notice
S002 2013-03-15 30-day Notice
S001 2012-09-12 30-day Notice

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