Atlas FDA

MENTOR MEMORYSHAPE BREAST IMPLANTS

FDA premarket approval P060028/S019 · decided 2017-05-08

Approval details

PMA number
P060028
Supplement
S019
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MENTOR MEMORYSHAPE BREAST IMPLANTS
Generic name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Applicant
Mentor Worldwide, LLC
Date received
2016-11-22
Decision date
2017-05-08
Days to decision
167 days
Decision code
APPR
Product code
FTR
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
Approval for implementation of a CO2 shell soaking process as an alternative to the current isopropyl alcohol (IPA) shell soaking process for removal of primarily low molecular weight (LMW) siloxanes from high temperature vulcanized (HTV) round and shaped breast implant shells.

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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