FDA.reportPublic FDA data

MENTOR

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16453371000118360MENTOR1N2026-01-013041 SKYWAY CIRCLE NORTH IRVING TX US 75038

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
355911661375709P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFWM2000-05-10
355911608985162P060028MENTOR MEMORYSHAPE BREAST IMPLANTSFTR2013-06-14
355912064789343P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTSFTR2006-11-17
355911152051327K981527MENTOR PATHWAY INTRODUCER/DILATORQPB1998-07-09
355911066584809K981215PSI-TEC LIPOSUCTION ASPIRATORQPB1998-07-01
355911007830419K981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESQPB1998-06-30
355911068961882K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGKGZ1998-02-10
355911612581036K842883RADOVAN TISSUE EXPANDERLCJ1984-08-17
355912044373264K780417ASEPTIC TRANSFER SETGAZ1978-04-18
355911481002702K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJ2025-01-12
355911419930633K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2025-01-13
355911830762334K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJ2024-08-02
355911942608549K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2024-09-06
355911926523184K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ2018-09-25
355911661589037K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJ2016-05-23
355911208373202K152496CPX 4 Breast Tissue ExpanderLCJ2016-02-19
355911088484147K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD2015-05-20
355911756760441K150777Artoura Breast Tissue ExpanderLCJ2015-04-24
355911721940518K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMRD2013-07-17
355911397547108K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSLCJ2013-04-11
355911448135728K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMRD2006-10-10
355911809214721K040149PSI-TEC PERISTALTIC INFILTRATION PUMPFRN2004-06-03
355911135638949K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERLCJ2001-12-03
355911297965014K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMRD2001-04-23
355911506150906K001803ACCELERATOR RECIPROCATING CANNULAQPB2000-08-04
355911700198888

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCJ92025-01-12
MRD62025-01-13
QPB42000-08-04
FTR22013-06-14
FRN12004-06-03
FWM12000-05-10
KGZ11998-02-10
GAZ11978-04-18