Product code FTR
- Device name
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Medical specialty
- General, Plastic Surgery
- Device class
- 3
- Regulation number
- 878.3540
- 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 7/9/91 per 56 fr 14627 on 4/10/91
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P030053S083 | MENTOR™ MemoryGel™ Enhance Breast Implants | Mentor Corp. | 2026-05-11 |
| P030053S089 | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corp. | 2026-05-01 |
| P030053S088 | MemoryGel Silicone Gel-Filled Breast Implant | Mentor Corp. | 2026-04-30 |
| P070004S048 | Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC | 2026-04-22 |
| P060028S060 | MENTOR™ MemoryShape™ Breast Implants | Mentor Worldwide, LLC | 2026-02-04 |
| P030053S087 | MENTOR™ MemoryGel™ Breast Implants | Mentor Corp. | 2026-02-04 |
| P060028S059 | MENTOR™ MemoryShape™ Breast Implants | Mentor Worldwide, LLC | 2026-01-02 |
| P030053S086 | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corp. | 2026-01-02 |
| P230005S003 | Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants | Motiva USA, LLC | 2025-12-17 |
| P060028S057 | MENTOR™ MemoryShape™ Breast Implants | Mentor Worldwide, LLC | 2025-12-17 |
| P030053S084 | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corp. | 2025-12-17 |
| P070004S045 | Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC | 2025-11-20 |
| P060028S055 | MemoryShape™ Silicone Gel-Filled Breast Implants | Mentor Worldwide, LLC | 2025-08-12 |
| P030053S080 | MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corp. | 2025-08-12 |
| P060028S056 | MENTOR™ MemoryShape™ Breast Implants | Mentor Worldwide, LLC | 2025-08-08 |
| P030053S082 | MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants | Mentor Corp. | 2025-08-08 |
| P030053S072 | Mentor MemoryGel® Breast Implants | Mentor Corp. | 2025-08-06 |
| P070004S047 | Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC | 2025-07-24 |
| P030053S077 | MENTOR MemoryGel Enhance Breast Implants | Mentor Corp. | 2025-07-03 |
| P030053S081 | MENTOR™ MemoryGel™ Enhance Breast Implants | Mentor Corp. | 2025-06-18 |
| P060028S054 | MENTOR MEMORYSHAPE BREAST IMPLANTS | Mentor Worldwide, LLC | 2025-05-21 |
| P030053S079 | MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS | Mentor Corp. | 2025-05-21 |
| P030053S078 | MENTOR™ MemoryGel™ Enhance Breast Implants | Mentor Corp. | 2025-02-14 |
| P030053S076 | MemoryGel Enhance Silicone Breast Implants | Mentor Corp. | 2025-01-17 |
| P020056S065 | NATRELLE Silicone-Filled Breast Implants | Allergan | 2024-12-16 |
| P060028S050 | Mentor® MemoryShape® Breast Implants | Mentor Worldwide, LLC | 2024-12-04 |
| P030053S071 | Mentor® MemoryGel® Silicone Gel-Filled Breast Implants | Mentor Corp. | 2024-12-04 |
| P060028S053 | MENTOR MemoryShape Breast Implants | Mentor Worldwide, LLC | 2024-11-26 |
| P030053S075 | MENTOR MemoryGel Breast Implants | Mentor Corp. | 2024-11-26 |
| P230005S001 | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas | Motiva USA, LLC | 2024-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07445161001924 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002136 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002129 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002112 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002105 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002099 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002082 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002075 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002068 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161002051 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001979 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001962 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001955 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001948 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001931 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001702 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001917 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001900 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001894 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001887 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001870 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001863 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001856 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001849 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001764 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001757 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001740 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001733 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001726 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |
| 07445161001719 | Motiva® SmoothSilk® Round Breast Implant | Establishment Labs S.A. | 2024-10-04 |