AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

FDA Premarket Approval P110007 S002

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 to the in-process bioburden testing.

DeviceAMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Generic NameAid, Surgical, Viscoelastic
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2013-03-15
Decision Date2013-04-09
PMAP110007
SupplementS002
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
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

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