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 for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (bia-alcl).
Device | Ideal Implant Saline-filled Breast Implant |
Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Applicant | IDEALIMPLANT |
Date Received | 2017-10-23 |
Decision Date | 2017-11-17 |
PMA | P120011 |
Supplement | S010 |
Product Code | FWM |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | IDEALIMPLANT 14881 Quorum Drive Suite 925 dallas, TX 75254 |
Supplement Number | Date | Supplement Type |
---|---|---|
P120011 | Original Filing | |
S024 | 2021-12-22 | 30-day Notice |
S023 | ||
S022 | 2021-05-27 | Normal 180 Day Track No User Fee |
S021 | 2020-11-03 | 135 Review Track For 30-day Notice |
S020 | 2020-07-02 | 30-day Notice |
S019 | ||
S018 | 2020-03-17 | 30-day Notice |
S017 | ||
S016 | 2019-06-21 | 30-day Notice |
S015 | ||
S014 | ||
S013 | 2018-07-25 | 30-day Notice |
S012 | 2018-06-11 | Real-time Process |
S011 | 2018-06-08 | 30-day Notice |
S010 | 2017-10-23 | Special (immediate Track) |
S009 | 2017-10-05 | Normal 180 Day Track No User Fee |
S008 | 2016-10-04 | 30-day Notice |
S007 | 2016-09-21 | 30-day Notice |
S006 | 2016-07-28 | Normal 180 Day Track No User Fee |
S005 | 2016-04-15 | 30-day Notice |
S004 | 2016-04-15 | 30-day Notice |
S003 | 2016-03-28 | 135 Review Track For 30-day Notice |
S002 | 2015-11-04 | Normal 180 Day Track No User Fee |
S001 | 2015-07-24 | 30-day Notice |