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.
Approval to add mechanical testing of sample shells produced as part of the incoming inspection process for the rtv silicone dispersion. This testing serves as an additional criterion for the acceptance of the raw material used to make all styles of the saline-filled breast implants.
| Device | MCGHAN RTV SALINE-FILLED BREAST IMPLANTS - STYLES 68, 163, 168, 363 AND 468 |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | Allergan |
| Date Received | 2001-08-31 |
| Decision Date | 2001-09-21 |
| PMA | P990074 |
| Supplement | S009 |
| Product Code | FWM |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| 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 |