Atlas FDA

Mentor Saline-Filled and SPECTRUM Breast Implants

FDA premarket approval P990075/S038 · decided 2017-04-04

Approval details

PMA number
P990075
Supplement
S038
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Mentor Saline-Filled and SPECTRUM Breast Implants
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2017-03-08
Decision date
2017-04-04
Days to decision
27 days
Decision code
OK30
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
Addition of Vinatoru equipment for seal strength testing of packaging components that are used for Mentor Saline-Filled and SPECTRUM® Breast Implants, MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShapeTM Breast Implants and their accessories.

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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