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 re-sterilization of the ideal implant® saline-filled breast implant up to a total of 44 hours exposure time if the primary dry heat sterilization (dhs) cycle is interrupted and/or aborted
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 | 2016-03-28 |
Decision Date | 2016-11-17 |
PMA | P120011 |
Supplement | S003 |
Product Code | FWM |
Advisory Committee | General & Plastic Surgery |
Supplement Type | 135 Review Track For 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 |