Approval for the ideal implant saline-filled breast implant. This device is indicated for women at least 18 years old undergoing:1) primary breast augmentation to increase breast size; and 2) revision breast augmentation to correct or improve the result of a primary breast augmentation surgery.
| 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 | 2012-06-25 |
| Decision Date | 2014-11-14 |
| Notice Date | 2014-11-25 |
| PMA | P120011 |
| Supplement | S |
| Product Code | FWM |
| Docket Number | 14M-2042 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IDEALIMPLANT 14881 Quorum Drive Suite 925 dallas, TX 75254 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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