Mentor

FDA Filings

This page includes the latest FDA filings for Mentor. 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

FDA Filings

Device Company	Device	Date
PMN K182335 | LCJ MENTOR [MENTOR Worldwide LLC]	Mentor CPX 4 Breast Tissue Expander with Smooth Surface	2018-10-22
PMN K161176 | LCJ MENTOR [MENTOR Worldwide LLC]	Artoura Breast Tissue Expanders With Smooth Surface	2016-05-31
PMN K152496 | LCJ MENTOR [MENTOR Worldwide LLC]	CPX4 Breast Tissue Expander 1445cc	2016-02-29
PMN K151055 | MRD MENTOR [MENTOR Worldwide LLC]	Sterile MemoryShape Resterilizable Gel Sizers	2015-06-30
PMN K150777 | LCJ MENTOR [MENTOR Worldwide LLC]	Artoura Breast Tissue Expander	2015-04-29
PMN K131853 | MRD MENTOR [MENTOR Worldwide LLC]	MemoryShape Gel Sizers	2013-12-12
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
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
PMN K974295 | KGZ MENTOR [MENTOR Worldwide LLC]	Tubing	2008-11-21
PMN K001803 | MUU MENTOR [MENTOR Worldwide LLC]	Byron Cannula	2008-07-02
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 [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 [MENTOR Worldwide LLC]	MemoryGel Resterilizable Gel Sizers	2008-03-07
PMN K011500 | LCJ MENTOR [MENTOR Worldwide LLC]	Contour Profile Tissue Expander (CPX)	2008-03-07
PMN K010709 | MRD MENTOR [MENTOR Worldwide LLC]	Saline Sizers	2008-03-07
PMN P060028 | FTR MENTOR [MENTOR Worldwide LLC]	MemoryShape Breast Implants	2008-02-15
PMN K981172 | MUU MENTOR [MENTOR Worldwide LLC]	Cannula	2006-06-14
MDM MENTOR [MENTOR Worldwide LLC]	Byron Cannula and Hand Instruments	2006-06-14

Similar & Related FDA Registered Companies

• Mentor Worldwide LLC
• MENTOR CORP.
• MENTOR MEDICAL LIMITED
• MENTOR OPHTHALMICS, INC.
• MENTOR UROLOGY, INC.
• MENTOR O & O, INC.
• 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
• Mentor Lab
• MENTORBIO
• MENTOR TEXAS L.P.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020051610942	FOS Sur Mer,France -> New York/Newark Area, Newark, New Jersey	SILICON MACHINE SERIAL NO. 12186 HS-CODE 84779080 .	3 CAS
2019061267862	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ CMAU7342170 DESCRIPTION--------- 1 PACKAGE 67 KGM 0.38 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U	1 PCS
2019061243280	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ TTNU9945310 DESCRIPTION--------- 71 KGM 0.53 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U FOR CYCLES OR MOTOR VEHICLES	1 PCS
2019052986235	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ FCIU6218659 DESCRIPTION--------- 67 KGM 0.38 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U FOR CYCLES OR MOTOR VEHICLES	1 PCS
2019051564419	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ CMAU4559964 DESCRIPTION--------- 71 KGM 1.06 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U FOR CYCLES OR MOTOR VEHICLES	1 PCS
2019051542648	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ CMAU6187167 DESCRIPTION--------- 2 PK PACKAGE 26 KGM 0.08 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U	2 PCS
2019042464821	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ APHU6864043 DESCRIPTION--------- 1 PACKAGE 224 KGM 0.7 MTQ SEATS (OTHER THAN THOSE OF HEADING 9402), WHE OR NOT CONVERTIBLE INTO BEDS, AND PARTS THE REOF	1 PCS
2019042462691	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	------------ TCNU3161318 DESCRIPTION--------- 1 PK PACKAGE 47 KGM 0.29 MTQ ELECTRICAL LIGHTING OR SIGNALLING EQUIPMENT (EXCLUDING ARTICLES OF HEADING 8539), WINDSCR WIPERS, DEFROSTERS AND DEMISTERS, OF A KIND U	1 PCS