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Device Explorer · FDA GUDID · GMDN 35223

Endocardial/interventricular septal pacing lead

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation i

US‑registered devices178in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic, Inc.5330%
Boston Scientific Corporation5229%
St. Jude Medical, Inc.4324%
Biotronik Se & Co. Kg2715%
Microport Crm Srl32%

Top labelers

CompanyDevicesShare
Medtronic, Inc.5330%
Boston Scientific Corporation5229%
St. Jude Medical, Inc.4324%
Biotronik Se & Co. Kg2715%
Microport Crm Srl32%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

UltiPace™Quartet™Tendril™Tendril MRI™Quickflex™Optisense™Isoflex™Solia CSP S 53Solia CSP S 60DHP-KitTILDATilda R 53 USTilda R 45 USDEXTRUSSolia

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

FDA product codes

CodeNameDevices
NVNDrug eluting permanent right ventricular (RV) or right atria229
DTBpermanent pacemaker Electrode215
NVYPermanent defibrillator electrodes165
OJXDrug eluting permanent left ventricular (lv) pacemaker elect25
NIKDefibrillator, automatic implantable cardioverter, with card21
LWPImplantable pulse generator, pacemaker (non-CRT)12

GMDN & GCC registration

  • GMDN code 35223 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · 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) · 243Catheter Gauge (French) · 15

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

No closely related category with 50+ devices.

How many endocardial/interventricular septal pacing lead products are registered in the US?

178 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endocardial/interventricular septal pacing lead", from 5 companies. The largest labeler is Medtronic, Inc. with 30% of records.

Which FDA product codes apply?

NVN (Drug eluting permanent right ventricular (RV) or right atria), DTB (permanent pacemaker Electrode), NVY (Permanent defibrillator electrodes), OJX (Drug eluting permanent left ventricular (lv) pacemaker elect)

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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