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.
| Device | MENTOR MemoryShape Breast Implants |
| Generic Name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled |
| Applicant | MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP060028 Supplement NumberS044 Date Received02/04/2022 Decision Date03/08/2022 Product Code FTR Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-03-08 |
| PMA | P060028 |
| Supplement | S044 |
| Product Code | FTR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENTOR WORLDWIDE LLC 33 Technology Drive irvine, CA 92618 PMA NumberP060028 Supplement NumberS044 Date Received02/04/2022 Decision Date03/08/2022 Product Code FTR Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Statistical Analysis Plan (SAP) For The Post-approval Study (PAS) Referenced Above. The SAP Has Been Submitted To Align With Protocol Changes Approved In Amendment 5 (P030053/S063 And P060028/S042). |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060028 | Original Filing | |
| S044 | 2022-02-04 | Normal 180 Day Track No User Fee |
| S043 | 2021-06-25 | 30-day Notice |
| S042 | ||
| S041 | ||
| S040 | 2021-05-07 | 30-day Notice |
| S039 | 2021-05-07 | 30-day Notice |
| S038 | ||
| S037 | ||
| S036 | 2020-09-28 | 30-day Notice |
| S035 | ||
| S034 | 2019-10-23 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | ||
| S029 | 2018-05-29 | 30-day Notice |
| S028 | ||
| S027 | 2017-11-06 | Special (immediate Track) |
| S026 | ||
| S025 | 2017-06-06 | Real-time Process |
| S024 | 2017-04-24 | 30-day Notice |
| S023 | 2017-03-27 | 30-day Notice |
| S022 | 2017-03-20 | 30-day Notice |
| S021 | 2017-03-14 | 30-day Notice |
| S020 | 2017-03-08 | 30-day Notice |
| S019 | 2016-11-22 | 135 Review Track For 30-day Notice |
| S018 | 2016-06-07 | 30-day Notice |
| S017 | ||
| S016 | 2016-02-11 | Normal 180 Day Track No User Fee |
| S015 | 2015-10-21 | 30-day Notice |
| S014 | 2015-09-30 | 135 Review Track For 30-day Notice |
| S013 | 2015-09-16 | Normal 180 Day Track No User Fee |
| S012 | 2015-06-10 | 30-day Notice |
| S011 | 2015-04-08 | 30-day Notice |
| S010 | 2015-04-02 | 30-day Notice |
| S009 | ||
| S008 | 2015-02-20 | 30-day Notice |
| S007 | 2015-02-20 | 30-day Notice |
| S006 | 2015-02-06 | 30-day Notice |
| S005 | 2014-12-22 | Normal 180 Day Track |
| S004 | 2014-12-08 | 30-day Notice |
| S003 | 2014-11-25 | 30-day Notice |
| S002 | 2014-09-23 | 30-day Notice |
| S001 | 2014-03-26 | Normal 180 Day Track |