FDA.report

Mentor Texas LP

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30054235193006165545Mentor Texas LP1N2026-01-01555 Airline Drive Coppell TX US 75019

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
861921661375709P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESESFWM2000-05-10
861921608985162P060028MENTOR MEMORYSHAPE BREAST IMPLANTSFTR2013-06-14
861922064789343P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTSFTR2006-11-17
861921612581036K842883RADOVAN TISSUE EXPANDERLCJ1984-08-17
861921481002702K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderLCJ2025-01-12
861921419930633K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2025-01-13
861921830762334K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderLCJ2024-08-02
861921942608549K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMRD2024-09-06
861921424363314K201115Next Generation Balloon Dilation SystemLRC2020-08-27
861921926523184K182335CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ2018-09-25
861921661589037K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceLCJ2016-05-23
861921675414805K153341Relieva Scout Multi-Sinus Dilation SystemLRC2016-02-12
861921208373202K152496CPX 4 Breast Tissue ExpanderLCJ2016-02-19
861921088484147K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMRD2015-05-20
861921756760441K150777Artoura Breast Tissue ExpanderLCJ2015-04-24
861921830897408K150172ACCLARENT SE Inflation DeviceLRC2015-04-07
861921525702657K143541Relieva SpinPlus Balloon Sinuplasty SystemLRC2015-04-22
861921721940518K131853MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZERMRD2013-07-17
861921397547108K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSLCJ2013-04-11
861921943803725K120280RELIEVA SEEKER BALLOON SINUPLASTY SYSTEMLRC2012-11-05
861921465178039K111875RELIEVA SPIN SINUS DILATION SYSTEMLRC2011-10-11
861922002504728K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETERLRC2011-08-22
861921259394191K110218INSPIRA AIR BALLOON DILATION SYSTEMKTI2011-03-31
861921554264187K110097ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPEEOB2011-05-27
861921522441595K090660AIRWAY BALLOON CATHETER INFLATION DEVICEKTI2009-06-12
861921937655283K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AKAM2007-09-28
861921448135728K062421MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZERMRD2006-10-10
861921146363971K052198RELIEVA SINUS BALLOON INFLATION DEVICELRC2005-08-31
861921135638949K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERLCJ2001-12-03
861921297965014K010709MENTOR STERILE SALINE MAMMARY VOLUME SIZERSMRD2001-04-23
861921271146102DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemPNZ2016-09-16
861921151220819
861921600821666
861921793744659
861922073649606

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LCJ92025-01-12
LRC82020-08-27
MRD62025-01-13
FTR22013-06-14
KTI22011-03-31
PNZ12016-09-16
EOB12011-05-27
KAM12007-09-28
FWM12000-05-10