Atlas FDA

MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

FDA premarket approval P990075/S062 · decided 2025-05-21

Approval details

PMA number
P990075
Supplement
S062
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2025-04-17
Decision date
2025-05-21
Days to decision
34 days
Decision code
OK30
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
for implementation of new mold release spray to be used on the rubber processing mill for silicone elastomers used in the manufacturing of MemoryGel™ (P030053), MemoryShape™ (P060028) and Saline-Filled/SPECTRUM™ Breast 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