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.
Change in the product lal testing from a release test for every sterilization lot, to a manufacturing change control tool used for process and material changes. There will be no adverse effect to the device as a result of changing the lal testing from a release test to a qualification test. Historical records of lal testing on finished product demonstrate the product manufacturing process is controlled and predictable, delivering an endotoxin-free product.
Device | SALINE FILLED BREAST IMPLANT |
Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Applicant | Allergan |
Date Received | 2000-11-29 |
Decision Date | 2000-12-15 |
PMA | P990074 |
Supplement | S003 |
Product Code | FWM |
Advisory Committee | General & Plastic Surgery |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Allergan 2525 Dupont Dr. irvine, CA 92612 |
Supplement Number | Date | Supplement Type |
---|---|---|
P990074 | Original Filing | |
S050 | 2022-04-04 | Real-time Process |
S049 | 2022-04-01 | 135 Review Track For 30-day Notice |
S048 | 2021-06-30 | 30-day Notice |
S047 | 2021-06-21 | 30-day Notice |
S046 | 2021-05-26 | 30-day Notice |
S045 | ||
S044 | 2020-06-30 | 30-day Notice |
S043 | 2019-11-04 | 30-day Notice |
S042 | 2018-07-02 | 30-day Notice |
S041 | 2017-10-02 | 30-day Notice |
S040 | 2017-07-20 | 30-day Notice |
S039 | 2017-06-07 | 30-day Notice |
S038 | 2017-04-13 | 135 Review Track For 30-day Notice |
S037 | 2017-03-01 | Normal 180 Day Track |
S036 | 2016-11-23 | Real-time Process |
S035 | 2016-11-07 | 30-day Notice |
S034 | 2016-09-30 | 30-day Notice |
S033 | 2016-09-07 | Special (immediate Track) |
S032 | 2014-09-29 | 30-day Notice |
S031 | 2014-09-15 | Normal 180 Day Track |
S030 | 2014-08-06 | Real-time Process |
S029 | 2014-05-30 | Normal 180 Day Track No User Fee |
S028 | 2013-12-31 | Real-time Process |
S027 | 2013-06-12 | 30-day Notice |
S026 | 2013-05-20 | 30-day Notice |
S025 | 2013-02-26 | 30-day Notice |
S024 | 2012-05-30 | 30-day Notice |
S023 | 2011-01-24 | Normal 180 Day Track No User Fee |
S022 | 2009-10-13 | 30-day Notice |
S021 | 2009-01-30 | 30-day Notice |
S020 | 2008-09-04 | Normal 180 Day Track No User Fee |
S019 | 2008-08-19 | 30-day Notice |
S018 | 2007-02-23 | Normal 180 Day Track No User Fee |
S017 | 2006-10-03 | Normal 180 Day Track No User Fee |
S016 | 2004-10-25 | Normal 180 Day Track No User Fee |
S015 | 2003-06-05 | Normal 180 Day Track No User Fee |
S014 | 2003-02-13 | Normal 180 Day Track |
S013 | 2002-08-09 | Normal 180 Day Track |
S012 | 2002-07-23 | Normal 180 Day Track |
S011 | 2002-06-17 | Normal 180 Day Track |
S010 | 2001-11-14 | 30-day Notice |
S009 | 2001-08-31 | Special (immediate Track) |
S008 | 2001-07-23 | 30-day Notice |
S007 | 2001-06-11 | 30-day Notice |
S006 | 2001-04-17 | Normal 180 Day Track |
S005 | 2001-01-29 | Normal 180 Day Track |
S004 | 2000-12-18 | Normal 180 Day Track |
S003 | 2000-11-29 | 30-day Notice |
S002 | 2000-06-09 | Normal 180 Day Track |
S001 | 2000-08-28 | Normal 180 Day Track |