TECNIS CL Foldable Silicone Posterior Chamber IOL

FDA Premarket Approval P880081 S046

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

Alternate ethylene oxide sterilization cycle parameters

DeviceTECNIS CL Foldable Silicone Posterior Chamber IOL
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-12-10
Decision Date2021-01-08
PMAP880081
SupplementS046
Product CodeHQL 
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
P880081Original Filing
S046 2020-12-10 30-day Notice
S045
S044
S043 2019-05-28 Special (immediate Track)
S042 2019-03-08 Special (immediate Track)
S041 2018-04-11 30-day Notice
S040 2016-06-02 30-day Notice
S039 2015-04-01 30-day Notice
S038 2012-12-31 30-day Notice
S037 2011-11-14 135 Review Track For 30-day Notice
S036 2008-01-28 30-day Notice
S035 2007-10-02 30-day Notice
S034 2007-09-24 30-day Notice
S033 2007-05-07 30-day Notice
S032 2006-05-30 Real-time Process
S031 2005-06-28 30-day Notice
S030 2005-01-03 Real-time Process
S029 2003-08-06 Special (immediate Track)
S028
S027 2001-11-19 Normal 180 Day Track
S026 2000-06-23 Normal 180 Day Track
S025
S024 1999-01-07 Normal 180 Day Track
S023 1997-06-30 Real-time Process
S022 1996-09-27 Normal 180 Day Track
S021
S020 1995-11-13 Normal 180 Day Track
S019 1995-11-03 Normal 180 Day Track
S018 1995-04-04 Normal 180 Day Track
S017 1993-08-03 Normal 180 Day Track
S016
S015
S014 1992-07-21 Normal 180 Day Track
S013 1992-06-30 Normal 180 Day Track
S012 1992-03-17 Normal 180 Day Track
S011 1992-02-04 Normal 180 Day Track
S010
S009 1991-01-25 Normal 180 Day Track
S008
S007 1990-08-02 Normal 180 Day Track
S006 1989-12-27 Normal 180 Day Track
S005 1990-02-28 Normal 180 Day Track
S004 1990-02-07 Normal 180 Day Track
S003 1989-12-15 Normal 180 Day Track
S002 1989-12-13 Normal 180 Day Track
S001 1989-08-25 Normal 180 Day Track

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