Mentor Worldwide L L C

FDA Filings

This page includes the latest FDA filings for Mentor Worldwide L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1645337
• FEI Number: 1000118360
• Name: MENTOR
• Owner & Operator: MENTOR Worldwide LLC
• Contact Address: 33 Technology Drive --; Irvine CA 92618 US
• Official Correspondent:
  • Manchi - Cheung
  • x-805-7082747-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3041 SKYWAY CIRCLE NORTH ; IRVING, TX 75038 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3005423519
• FEI Number: 3006165545
• Name: Mentor Texas LP
• Owner & Operator: MENTOR Worldwide LLC
• Contact Address: 33 Technology Drive --; Irvine CA 92618 US
• Official Correspondent:
  • Manchi - Cheung
  • x-805-7082747-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 555 Airline Drive ; Coppell, TX 75019 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMA P060028S043 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2021-07-22
PMA P990075S052 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and Spectrum Breast Implants	2021-07-21
PMA P990075S050 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and Spectrum Breast Implants	2021-06-04
PMA P060028S040 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2021-06-04
PMA P060028S039 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2021-06-04
PMA P990075S049 MENTOR WORLDWIDE LLC	Saline-Filled and Spectrum Breast Implants	2020-12-01
PMA P990075S048 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and SPECTRUM Breast Implants	2020-10-30
PMA P990075S047 MENTOR WORLDWIDE LLC	Mentor Saline-Filled Breast Implants	2020-10-27
PMA P060028S036 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2020-10-27
PMA P990075S046 MENTOR WORLDWIDE LLC	Saline-Filled and Spectrum Breast Implants	2019-11-19
PMA P060028S034 MENTOR WORLDWIDE LLC	MemoryShape Silicone Gel-Filled Breast Implants	2019-11-19
PMA P990075S045 MENTOR WORLDWIDE LLC	Spectrum Saline-Filled Breast Implants	2019-07-24
PMN K182335 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Mentor CPX 4 Breast Tissue Expander with Smooth Surface	2018-10-22
PMN K182335 | LCJ MENTOR [MENTOR Worldwide LLC]	Mentor CPX 4 Breast Tissue Expander with Smooth Surface	2018-10-22
PMN K182335 Mentor Worldwide LLC	CPX 4 Breast Tissue Expander With Smooth Surface	2018-09-25
PMA P990075S044 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and SPECTRUM Breast Implants	2018-06-26
PMA P060028S029 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2018-06-26
PMA P990075S043 MENTOR WORLDWIDE LLC	Mentor-Saline-Filled and Spectrum Breast Implants	2017-12-06
PMA P060028S027 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2017-12-06
PMA P060028S025 MENTOR WORLDWIDE LLC	Mentor MemoryShape Silicone Gel-Filled Breast Implants	2017-09-01
PMA P990075S042 MENTOR WORLDWIDE LLC	Spectrum Saline Breast Implants	2017-08-09
PMA P990075S041 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and SPECTRUM® Breast Implants	2017-05-24
PMA P060028S024 MENTOR WORLDWIDE LLC	Mentor MemoryShape™ Breast Implants	2017-05-24
PMA P060028S019 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2017-05-08
PMA P990075S040 MENTOR WORLDWIDE LLC	Mentor Saline Filled and Spectrum Breast Implants	2017-05-01
PMA P060028S023 MENTOR WORLDWIDE LLC	Mentor Memoryshape, Breast Implants	2017-05-01
PMA P060028S022 MENTOR WORLDWIDE LLC	Mentor MenoryShape Breast Implants	2017-04-19
PMA P990075S039 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and Spectrum Breast Implants	2017-04-10
PMA P060028S021 MENTOR WORLDWIDE LLC	Mentor Memory Shape Breast Implants	2017-04-10
PMA P990075S038 MENTOR WORLDWIDE LLC	Mentor Saline-Filled and SPECTRUM Breast Implants	2017-04-04
PMA P060028S020 MENTOR WORLDWIDE LLC	Mentor MemoryShape Breast Implants	2017-04-04
PMA P060028S016 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2016-12-20
PMN K153341 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	Scout? Multi-Sinus Dilation System	2016-09-26
PMN DEN150056 | PNZ Mentor Texas LP [MENTOR Worldwide LLC]	Aera Eustachian Tube Balloon Dilation System	2016-09-16
PMA P990075S037 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS	2016-07-05
PMA P060028S018 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2016-07-05
PMN K161176 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Artoura Breast Tissue Expanders With Smooth Surface	2016-05-31
PMN K161176 | LCJ MENTOR [MENTOR Worldwide LLC]	Artoura Breast Tissue Expanders With Smooth Surface	2016-05-31
PMN K161176 MENTOR WORLDWIDE LLC	ARTOURA Breast Tissue Expanders With Smooth Surface	2016-05-23
PMA P990075S036 MENTOR WORLDWIDE LLC	MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES	2016-04-15
PMN K152496 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	CPX4 Breast Tissue Expander 1445cc	2016-02-29
PMN K152496 | LCJ MENTOR [MENTOR Worldwide LLC]	CPX4 Breast Tissue Expander 1445cc	2016-02-29
PMN K152496 MENTOR WORLDWIDE LLC	CPX 4 Breast Tissue Expander	2016-02-19
PMA P060028S013 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS	2016-02-12
PMA P060028S014 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2016-02-05
PMN K143541 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	SpinPlus	2016-01-12
KAX Mentor Texas LP [MENTOR Worldwide LLC]	Circa	2016-01-12
PMA P990075S035 MENTOR WORLDWIDE LLC	SPECTRUM BREAST IMPLANTS	2016-01-07
PMN K150172 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	ACCLARENT SE Inflation Device	2015-12-15
PMN K120280 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Scout Sinus Dilation System	2015-12-15
PMN K071845 | KAM Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Luma Sinus Illumination System	2015-12-15
PMN K071845 | KAM Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Luma Sentry Sinus Illumination System	2015-12-15
PMN K052198 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	Acclarent Inflation Device	2015-12-15
KAR Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Vortex 2	2015-12-15
EQH Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Luma Light Guide Cable 2	2015-12-15
EQH Mentor Texas LP [MENTOR Worldwide LLC]	Light Guide Cable Adapters	2015-12-15
PMA P990075S034 MENTOR WORLDWIDE LLC	SALINE-FILLED & SPECTRUM BREAST IMPLANTS	2015-11-20
PMA P060028S015 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS	2015-11-20
PMN K111875 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Spin Balloon Sinuplasty System	2015-09-10
PMN K111254 | LRC Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Ultirra Sinus Balloon Catheter	2015-09-10
PMN K110218 | KTI Mentor Texas LP [MENTOR Worldwide LLC]	Inspira Air Balloon Dilation System	2015-09-10
PMN K110097 | EOB Mentor Texas LP [MENTOR Worldwide LLC]	Cyclops Multi-Angle Endoscope	2015-09-10
PMN K090660 | KTI Mentor Texas LP [MENTOR Worldwide LLC]	Inspira Air Balloon Dilation System	2015-09-10
KAM Mentor Texas LP [MENTOR Worldwide LLC]	Sinus Guidewire	2015-09-10
KAM Mentor Texas LP [MENTOR Worldwide LLC]	Sinus Guide Catheters	2015-09-10
KAM Mentor Texas LP [MENTOR Worldwide LLC]	Sidekick	2015-09-10
KAM Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Sidekick LP	2015-09-10
KAM Mentor Texas LP [MENTOR Worldwide LLC]	Relieva Flex Guide Catheter	2015-09-10
PMA P990075S033 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT	2015-07-01
PMA P060028S012 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-07-01
PMN K151055 | MRD Mentor Texas LP [MENTOR Worldwide LLC]	Sterile MemoryShape Resterilizable Gel Sizers	2015-06-30
PMN K151055 | MRD MENTOR [MENTOR Worldwide LLC]	Sterile MemoryShape Resterilizable Gel Sizers	2015-06-30
PMN K151055 MENTOR WORLDWIDE LLC	Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE	2015-05-20
PMA P060028S011 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-05-08
PMA P990075S032 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS	2015-04-29
PMA P060028S010 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-04-29
PMN K150777 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Artoura Breast Tissue Expander	2015-04-29
PMN K150777 | LCJ MENTOR [MENTOR Worldwide LLC]	Artoura Breast Tissue Expander	2015-04-29
PMN K150777 MENTOR WORLDWIDE LLC	Artoura Breast Tissue Expander	2015-04-24
PMA P060028S008 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-03-19
PMA P060028S007 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-03-17
PMA P060028S006 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS	2015-03-05
PMA P060028S005 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2015-03-02
PMN K142998 MENTOR WORLDWIDE LLC	CPX Control Breast Tissue Expander	2014-12-19
PMA P990075S031 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS	2014-12-16
PMA P060028S004 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS	2014-12-16
PMA P990075S030 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS	2014-12-15
PMA P060028S003 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2014-12-15
PMA P990075S029 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT	2014-11-26
PMA P990075S028 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES	2014-11-19
PMA P990075S027 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS	2014-10-29
PMA P060028S002 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS	2014-10-29
PMA P060028S001 MENTOR WORLDWIDE LLC	MEMORYSHAPE BREAST IMPLANTS, CONTOUR PROFILE GEL IMPLANTS	2014-09-09
PMA P990075S026 MENTOR WORLDWIDE LLC	SPECTRUM BREAST IMPLANTS	2014-08-12
PMA P990075S025 MENTOR WORLDWIDE LLC	MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS	2014-02-20
PMN K131853 | MRD Mentor Texas LP [MENTOR Worldwide LLC]	MemoryShape Gel Sizers	2013-12-12
PMN K131853 | MRD MENTOR [MENTOR Worldwide LLC]	MemoryShape Gel Sizers	2013-12-12
PMA P990075S022 MENTOR WORLDWIDE LLC	SALINE-FILLED & SPECTRUM BREAST IMPLANTS	2013-10-08
PMA P990075S024 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM BREAST IMPLANTS	2013-08-20
PMN K131853 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER	2013-07-17
PMA P060028 MENTOR WORLDWIDE LLC	MENTOR MEMORYSHAPE BREAST IMPLANTS	2013-06-14
PMN K130813 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Mentor CPX 4 Breast Tissue Expanders And Mentor CPX 4 With Suture Tabs Breast Tissue Expanders	2013-06-03
PMN K130813 | LCJ MENTOR [MENTOR Worldwide LLC]	Mentor CPX 4 Breast Tissue Expanders And Mentor CPX 4 With Suture Tabs Breast Tissue Expanders	2013-06-03
PMA P990075S023 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED BREAST IMPLANTS	2013-05-15
PMN K981215 | MUU MENTOR [MENTOR Worldwide LLC]	PSI-TEC Aspirators	2010-12-10
PMN K981527 | MUU MENTOR [MENTOR Worldwide LLC]	Pathway Introducer	2009-09-02
PMN K040149 | FRN MENTOR [MENTOR Worldwide LLC]	PT-PINF-III	2009-09-02
PMA P990075S021 MENTOR WORLDWIDE LLC	MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS	2009-03-31
PMN K974295 | KGZ MENTOR [MENTOR Worldwide LLC]	Tubing	2008-11-21
PMA P990075S019 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS	2008-07-28
PMN K001803 | MUU MENTOR [MENTOR Worldwide LLC]	Byron Cannula	2008-07-02
PMN P990075 | FWM Mentor Texas LP [MENTOR Worldwide LLC]	Spectrum Saline Implants	2008-03-07
PMN P990075 | FWM Mentor Texas LP [MENTOR Worldwide LLC]	Siltex Contour Profile Saline Implants	2008-03-07
PMN P990075 | FWM Mentor Texas LP [MENTOR Worldwide LLC]	Saline Implants	2008-03-07
PMN P990075 | FWM MENTOR [MENTOR Worldwide LLC]	Spectrum Saline Implants	2008-03-07
PMN P990075 | FWM MENTOR [MENTOR Worldwide LLC]	Siltex Contour Profile Saline Implants	2008-03-07
PMN P990075 | FWM MENTOR [MENTOR Worldwide LLC]	Saline Implants	2008-03-07
PMN K842883 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Smooth Tissue Expanders	2008-03-07
PMN K842883 | LCJ MENTOR [MENTOR Worldwide LLC]	Smooth Tissue Expanders	2008-03-07
PMN K780417 | GAZ MENTOR [MENTOR Worldwide LLC]	Aseptic Transfer Kit	2008-03-07
PMN K062421 | MRD Mentor Texas LP [MENTOR Worldwide LLC]	MemoryGel Resterilizable Gel Sizers	2008-03-07
PMN K062421 | MRD MENTOR [MENTOR Worldwide LLC]	MemoryGel Resterilizable Gel Sizers	2008-03-07
PMN K011500 | LCJ Mentor Texas LP [MENTOR Worldwide LLC]	Contour Profile Tissue Expander (CPX)	2008-03-07
PMN K011500 | LCJ MENTOR [MENTOR Worldwide LLC]	Contour Profile Tissue Expander (CPX)	2008-03-07
PMN K010709 | MRD Mentor Texas LP [MENTOR Worldwide LLC]	Saline Sizers	2008-03-07
PMN K010709 | MRD MENTOR [MENTOR Worldwide LLC]	Saline Sizers	2008-03-07
PMN P060028 | FTR Mentor Texas LP [MENTOR Worldwide LLC]	MemoryShape Breast Implants	2008-02-15
PMN P060028 | FTR MENTOR [MENTOR Worldwide LLC]	MemoryShape Breast Implants	2008-02-15
PMA P990075S017 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANTS	2007-03-19
PMN K981172 | MUU MENTOR [MENTOR Worldwide LLC]	Cannula	2006-06-14
MDM MENTOR [MENTOR Worldwide LLC]	Byron Cannula and Hand Instruments	2006-06-14
PMA P990075S015 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS	2006-01-20
PMA P990075S016 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS	2005-07-27
PMA P990075S014 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS	2004-01-16
PMA P990075S012 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES	2003-08-15
PMA P990075S013 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM SALINE-FILLED MAMMARY PROSTHESES	2003-08-14
PMA P990075S011 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED BREAST IMPLANT	2003-03-26
PMA P990075S010 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED BREAST IMPLANTS	2003-03-07
PMA P990075S009 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS.	2002-09-03
PMA P990075S008 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES	2002-06-07
PMA P990075S007 MENTOR WORLDWIDE LLC	MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES	2002-04-23
PMA P990075S005 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED MAMMARY PROSTHESES	2001-10-31
PMA P990075S004 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS - STYLES 5000 AND 5000PT AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY	2001-09-05
PMA P990075S006 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED BREAST IMPLANTS	2001-08-09
PMA P990075S003 MENTOR WORLDWIDE LLC	HIGH PROFILE ROUND SALINE-FILLED BREAST IMPLANT, STYLE 3000	2001-06-18
PMA P990075S001 MENTOR WORLDWIDE LLC	SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS	2001-02-27
PMA P990075S002 MENTOR WORLDWIDE LLC	MENTOR SALINE-FILLED MAMMARY PROSTHESES	2000-12-22
PMA P990075 MENTOR WORLDWIDE LLC	MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES	2000-05-10

Similar & Related FDA Registered Companies

• MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP990075 Supplement NumberS054 Date Received05/10/2022 Decision Date11/16/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP060028 Supplement NumberS044 Date Received02/04/2022 Decision Date03/08/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	66580	MENTOR WORLDWIDE LLC
CAGE Code	66580	MENTOR WORLDWIDE LLC
S.A.M. Registration	66580 [46712931]	MENTOR WORLDWIDE LLC