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.
Device | SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR |
Generic Name | Intraocular Lens |
Applicant | Johnson & Johnson Surgical Vision, Inc. |
Date Received | 1990-02-07 |
Decision Date | 1990-09-11 |
PMA | P880081 |
Supplement | S004 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
Supplement Number | Date | Supplement Type |
---|---|---|
P880081 | Original Filing | |
S047 | 2022-11-09 | 30-day Notice |
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 |