Healon EndoCoat Ophtalmic Viscosurgical s (OVD) (3% Sodium Hyaluronate)

FDA Premarket Approval P110007 S012

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)

DeviceHealon EndoCoat Ophtalmic Viscosurgical s (OVD) (3% Sodium Hyaluronate)
Generic NameAid, Surgical, Viscoelastic
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-04-29
Decision Date2020-05-11
PMAP110007
SupplementS012
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
P110007Original Filing
S012 2020-04-29 30-day Notice
S011 0000-00-00
S010
S009 0000-00-00
S008 0000-00-00
S007 0000-00-00
S006 0000-00-00
S005 0000-00-00
S004 0000-00-00
S003 0000-00-00
S002 0000-00-00
S001 2012-09-12 30-day Notice

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