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 |
Supplemental Filings
| 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 |
NIH GUDID Devices