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MENTOR MEMORYSHAPE BREAST IMPLANTS

FDA premarket approval P060028/S008 · decided 2015-03-19

Approval details

PMA number
P060028
Supplement
S008
Supplement type
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
2015-02-20
Decision date
2015-03-19
Days to decision
27 days
Decision code
OK30
Product code
FTR
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
CHANGES IN THE PRODUCTION OF MEMORYSHAPE BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY. THE CHANGES INCLUDE EXPANDING THE GOWNING AREA, INCREASING THE NUMBER OF DRYING RODS IN THE SHELL DRYING OVEN AND UPDATING THE BOWL FILL PROCEDURE.

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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