Chrysalis Intelligence · Sponsors · Mentor Worldwide, LLC

Mentor Worldwide, LLC

Irvine, CA, US · 5 510(k) clearances · 44 PMAs

Total clearances
5
2024-08-02 → 2025-04-24
Last 12 months
0
Product codes
2
Most recent
2025-04-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LCJ Tissue Expander And Accessories Unclassified Unknown 3 2025-04-24
MRD 2 2025-01-13
Class III

PMA approvals (44)

Total PMA records
44
Originals + supplements
Distinct product codes
2
First decision
2020-07-01
Most recent
2026-07-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-21 P060028-S058 MENTOR™ MemoryShape™ Breast Implants Normal 180 Day Track No User Fee FTR
2026-05-12 P990075-S068 MENTOR Saline-Filled and Spectrum™ Breast Implants 30-Day Notice FWM
2026-02-04 P990075-S067 MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants 30-Day Notice FWM
2026-02-04 P060028-S060 MENTOR™ MemoryShape™ Breast Implants 30-Day Notice FTR
2026-01-02 P060028-S059 MENTOR™ MemoryShape™ Breast Implants 30-Day Notice FTR
2025-12-17 P990075-S066 MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants 30-Day Notice FWM
2025-12-17 P060028-S057 MENTOR™ MemoryShape™ Breast Implants 30-Day Notice FTR
2025-11-18 P990075-S065 MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants 135 Review Track For 30-Day Notice FWM
2025-08-12 P990075-S063 Saline and SPECTRUM™ Saline-Filled Breast Implants 30-Day Notice FWM
2025-08-12 P060028-S055 MemoryShape™ Silicone Gel-Filled Breast Implants 30-Day Notice FTR
2025-08-08 P990075-S064 MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants 30-Day Notice FWM
2025-08-08 P060028-S056 MENTOR™ MemoryShape™ Breast Implants 30-Day Notice FTR
2025-05-21 P990075-S062 MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES 30-Day Notice FWM
2025-05-21 P060028-S054 MENTOR MEMORYSHAPE BREAST IMPLANTS 30-Day Notice FTR
2024-12-04 P990075-S059 Mentor® Saline-Filled and SPECTRUM® Breast Implants 135 Review Track For 30-Day Notice FWM
2024-12-04 P060028-S050 Mentor® MemoryShape® Breast Implants 135 Review Track For 30-Day Notice FTR
2024-11-26 P990075-S061 MENTOR Saline-Filled and SPECTRUM Breast Implants 30-Day Notice FWM
2024-11-26 P060028-S053 MENTOR MemoryShape Breast Implants 30-Day Notice FTR
2024-11-05 P060028-S052 Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA Normal 180 Day Track FTR
2024-03-11 P990075-S060 Mentor Saline-Filled and SPECTRUM® Breast Implants Real-Time Process FWM
2024-03-11 P060028-S051 Mentor MemoryShape® Silicone Gel-Filled Breast Implant Real-Time Process FTR
2023-08-23 P990075-S053 Saline-Filled and Spectrum Breast Implants 135 Review Track For 30-Day Notice FWM
2023-08-08 P060028-S049 Mentor MemoryShape Silicone Gel-Filled Breast Implants 30-Day Notice FTR
2023-06-02 P990075-S058 Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants 30-Day Notice FWM
2023-06-02 P990075-S057 Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants 30-Day Notice FWM
2023-05-24 P990075-S056 Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants 30-Day Notice FWM
2023-05-24 P060028-S048 Mentor MemoryShape Breast Implants 30-Day Notice FTR
2022-11-16 P990075-S054 Spectrum Breast Implants 135 Review Track For 30-Day Notice FWM
2022-03-08 P060028-S044 MENTOR MemoryShape Breast Implants Normal 180 Day Track No User Fee FTR
2021-12-10 P060028-S042 MENTOR MemoryShape Breast Implants Normal 180 Day Track No User Fee FTR
2021-10-27 P990075-S051 Saline-Filled and Spectrum Breast Implants Normal 180 Day Track FWM
2021-10-27 P060028-S041 MemoryShape Breast Implants Normal 180 Day Track FTR
2021-09-24 P060028-S038 Mentor MemoryShape Breast Implants 135 Review Track For 30-Day Notice FTR
2021-07-22 P060028-S043 Mentor MemoryShape Breast Implants 30-Day Notice FTR
2021-07-21 P990075-S052 Mentor Saline-Filled and Spectrum Breast Implants 30-Day Notice FWM
2021-06-04 P990075-S050 Mentor Saline-Filled and Spectrum Breast Implants 30-Day Notice FWM
2021-06-04 P060028-S040 Mentor MemoryShape Breast Implants 30-Day Notice FTR
2021-06-04 P060028-S039 Mentor MemoryShape Breast Implants 30-Day Notice FTR
2020-12-01 P990075-S049 Saline-Filled and Spectrum Breast Implants 30-Day Notice FWM
2020-10-30 P990075-S048 Mentor Saline-Filled and SPECTRUM Breast Implants 30-Day Notice FWM
2020-10-27 P990075-S047 Mentor Saline-Filled Breast Implants 30-Day Notice FWM
2020-10-27 P060028-S036 Mentor MemoryShape Breast Implants 30-Day Notice FTR
2020-07-01 P060028-S033 Mentor MemoryShape Breast Implants Normal 180 Day Track No User Fee FTR
2020-07-01 P060028-S032 MENTOR MEMORYSHAPE BREAST IMPLANTS Normal 180 Day Track No User Fee FTR
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-04-24 K242963 MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs LCJ Unclassified Unknown
2025-01-13 K243271 MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer MRD
2025-01-12 K243836 Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander LCJ Unclassified Unknown
2024-09-06 K241552 MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer MRD
2024-08-02 K241918 MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander LCJ Unclassified Unknown