FDA.reportPublic FDA data

TORAX MEDICAL, INC.

Matched from indexed company URL: Torax Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087660733008766073TORAX MEDICAL, INC.1N2026-01-014545 Creek Road Cincinnati OH US 45242

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00855106005219LINX - LINX Esophagus Sizing Tools+1(877)384-4266customersupport@eesus.jnj.com
00855106005332LINX - LINX Reflux Management System+1(877)384-4266customersupport@eesus.jnj.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1398371050514665P100049LINX REFLUX MANAGEMENT SYSTEMLEI2012-03-22
1398371278819178K230089ETHICON LINX® Esophagus Sizing ToolQJN2023-02-09
1398372051534573K201035ETHICON Linx Esophagus Sizing ToolQJN2020-07-09
1398372067425349H130006

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJN22023-02-09
LEI12012-03-22

PMA#

LINX Reflux Management System

2022-06-09

TORAX MEDICAL4188 Lexington Avenue Northshoreview, MN 55126 PMA NumberP100049 Supplement NumberS034 Date Received05/10/2022 Decision Date06/09/2022 Product Code LEI  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason ...

PMN#

GUDID#