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MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS

FDA premarket approval P990075/S027 · decided 2014-10-29

Approval details

PMA number
P990075
Supplement
S027
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS
Generic name
Prosthesis, breast, inflatable, internal, saline
Applicant
Mentor Worldwide, LLC
Date received
2014-09-23
Decision date
2014-10-29
Days to decision
36 days
Decision code
OK30
Product code
FWM
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Irvin, CA
Statement
CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.

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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