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Device Explorer · FDA GUDID · GMDN 35853

Endocardial defibrillation lead

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implant

US‑registered devices203in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic, Inc.5527%
Boston Scientific Corporation5226%
St. Jude Medical, Inc.4924%
Biotronik Se & Co. Kg4422%
Oscor Inc.21%
Cameron Health, Inc.10%

Top labelers

CompanyDevicesShare
Medtronic, Inc.5527%
Boston Scientific Corporation5226%
St. Jude Medical, Inc.4924%
Biotronik Se & Co. Kg4422%
Oscor Inc.21%
Cameron Health, Inc.10%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OPTISURE™Optisure™Durata™Plexa ProMRIPamira S DX 65/17Pamira S DX 65/15Pamira SD 75/18Pamira SD 65/18Pamira SD 65/16Pamira SD 60/16Pamira S 75Pamira S 65Pamira S 60Plexa ProMRI DF-1 SD 60/16Plexa ProMRI DF-1Plexa ProMRI DF-1 S 60

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NVYPermanent defibrillator electrodes269
DTBpermanent pacemaker Electrode109
LWSImplantable cardioverter defibrillator (non-CRT)86
DXYimplantable pacemaker Pulse-generator3
DTBPermanent Pacemaker Electrode1

GMDN & GCC registration

  • GMDN code 35853 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 182Catheter Gauge (French) · 6Lumen/Inner Diameter (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many endocardial defibrillation lead products are registered in the US?

203 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endocardial defibrillation lead", from 6 companies. The largest labeler is Medtronic, Inc. with 27% of records.

Which FDA product codes apply?

NVY (Permanent defibrillator electrodes), DTB (permanent pacemaker Electrode), LWS (Implantable cardioverter defibrillator (non-CRT)), DXY (implantable pacemaker Pulse-generator)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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