Product code FWM
- Device name
- Prosthesis, Breast, Inflatable, Internal, Saline
- Medical specialty
- General, Plastic Surgery
- Device class
- 3
- Regulation number
- 878.3530
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990075S068 | MENTOR Saline-Filled and Spectrum™ Breast Implants | Mentor Worldwide, LLC | 2026-05-12 |
| P990075S067 | MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants | Mentor Worldwide, LLC | 2026-02-04 |
| P990075S066 | MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants | Mentor Worldwide, LLC | 2025-12-17 |
| P990075S065 | MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants | Mentor Worldwide, LLC | 2025-11-18 |
| P990075S063 | Saline and SPECTRUM™ Saline-Filled Breast Implants | Mentor Worldwide, LLC | 2025-08-12 |
| P990075S064 | MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants | Mentor Worldwide, LLC | 2025-08-08 |
| P990075S062 | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | Mentor Worldwide, LLC | 2025-05-21 |
| P120011S028 | Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant | Bimini Health Tech | 2025-02-11 |
| P990074S054 | NATRELLE Saline-Filled Breast Implants | Allergan | 2024-12-16 |
| P990075S059 | Mentor® Saline-Filled and SPECTRUM® Breast Implants | Mentor Worldwide, LLC | 2024-12-04 |
| P990075S061 | MENTOR Saline-Filled and SPECTRUM Breast Implants | Mentor Worldwide, LLC | 2024-11-26 |
| P120011S025 | Puregraft Serene Breast Implant | Bimini Health Tech | 2024-08-16 |
| P990074S053 | NATRELLE® Saline-Filled Breast Implants | Allergan | 2024-06-21 |
| P120011S026 | Puregraft Serene Breast Implant | Bimini Health Tech | 2024-03-15 |
| P990075S060 | Mentor Saline-Filled and SPECTRUM® Breast Implants | Mentor Worldwide, LLC | 2024-03-11 |
| P120011S027 | Ideal Implant Structured Breast implant | Bimini Health Tech | 2023-11-18 |
| P990075S053 | Saline-Filled and Spectrum Breast Implants | Mentor Worldwide, LLC | 2023-08-23 |
| P990075S058 | Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants | Mentor Worldwide, LLC | 2023-06-02 |
| P990075S057 | Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants | Mentor Worldwide, LLC | 2023-06-02 |
| P990075S056 | Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants | Mentor Worldwide, LLC | 2023-05-24 |
| P120011S023 | IDEAL IMPLANT® Structured Breast Implant | Bimini Health Tech | 2023-02-01 |
| P990074S050 | NATRELLE Saline-Filled Breast Implants | Allergan | 2022-12-29 |
| P990075S054 | Spectrum Breast Implants | Mentor Worldwide, LLC | 2022-11-16 |
| P990074S049 | NATRELLE Silicone-Filled Breast Implants | Allergan | 2022-10-05 |
| P120011S024 | IDEAL IMPLANT Structured Breast Implant | Bimini Health Tech | 2022-01-26 |
| P990075S051 | Saline-Filled and Spectrum Breast Implants | Mentor Worldwide, LLC | 2021-10-27 |
| P990074S045 | Natrelle Saline Filled Breast Implants | Allergan | 2021-10-27 |
| P120011S022 | IDEAL IMPLANT Structured Breast Implant | Bimini Health Tech | 2021-10-27 |
| P990074S048 | NATRELLE Saline-Filled Breast Implants | Allergan | 2021-07-30 |
| P990075S052 | Mentor Saline-Filled and Spectrum Breast Implants | Mentor Worldwide, LLC | 2021-07-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10081317028694 | MENTOR Smooth Round Moderate Plus Profile | MENTOR TEXAS L.P. | 2025-03-17 |
| 10081317028687 | MENTOR Smooth Round Moderate Plus Profile | MENTOR TEXAS L.P. | 2025-03-17 |
| 10081317028670 | MENTOR Smooth Round Moderate Plus Profile | MENTOR TEXAS L.P. | 2025-03-17 |
| 00850034511283 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511917 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511870 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511856 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511818 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511788 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511764 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511689 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511665 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511641 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511436 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511368 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 00850034511092 | Puregraft Serene Breast Implant | Bimini Technologies LLC | 2024-03-28 |
| 10851795006008 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006138 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006121 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006114 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006107 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006091 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006084 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006077 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006060 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006053 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006046 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006039 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006022 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |
| 10851795006015 | IDEAL IMPLANT | IDEAL IMPLANT INCORPORATED | 2015-09-09 |