Extra valve competence testing on valves prior to assembly into implants, implemented during commercial production start-up, will be discontinued; andthe extra valve competence testing on valves in finished (i. E. , packaged and sterilized) implants during commercial production start-up, will be discontinued. However, valve competence testing on valves in finished implants will continue to meet the requirements of the aql sampling specified in ideal implant’s finished product specification fp 001.
| 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 | 2016-09-21 |
| Decision Date | 2016-10-20 |
| PMA | P120011 |
| Supplement | S007 |
| 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 | 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