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.
Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in specialty silicone fabricators (ssf), 2761 walnut avenue, tustin, california, 92780.
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 | 2016-04-15 |
Decision Date | 2016-05-11 |
PMA | P120011 |
Supplement | S004 |
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 |