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.
Change to the bubble specification for the inner and outer shell to increase the allowable number of microscopic bubbles less than or equal to 0. 020 inches in size from 5 bubbles to 10 bubbles.
Device | Ideal Implant Structured Breast Implant |
Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
Applicant | IDEALIMPLANT |
Date Received | 2018-06-08 |
Decision Date | 2018-06-28 |
PMA | P120011 |
Supplement | S011 |
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 |
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 |