Atlas FDA

Mentor MemoryShape Silicone Gel-Filled Breast Implants

FDA premarket approval P060028/S025 · decided 2017-09-01

Approval details

PMA number
P060028
Supplement
S025
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Mentor MemoryShape Silicone Gel-Filled Breast Implants
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Applicant
Mentor Worldwide, LLC
Date received
2017-06-06
Decision date
2017-09-01
Days to decision
87 days
Decision code
APPR
Product code
FTR
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
Approval of a product line extension to the currently marketed MemoryShape Silicone Gel-Filled Breast Implants product line involving additional breast implant options with volume and dimensional values that are bracketed within the currently approved ranges for the commercially available MemoryShape implants.

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510(k) clearances by this applicant

RecordFirmDate
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963)Mentor Worldwide, LLC2025-04-24
MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271)Mentor Worldwide, LLC2025-01-13
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836)Mentor Worldwide, LLC2025-01-12
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552)Mentor Worldwide, LLC2024-09-06
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918)Mentor Worldwide, LLC2024-08-02
CPX 4 Breast Tissue Expander with Smooth Surface (K182335)Mentor Worldwide, LLC2018-09-25
ARTOURA Breast Tissue Expanders with Smooth Surface (K161176)Mentor Worldwide, LLC2016-05-23
CPX 4 Breast Tissue Expander (K152496)Mentor Worldwide, LLC2016-02-19