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Device Explorer · FDA GUDID · GMDN 47265

Dual-chamber implantable pacemaker, rate-responsive

A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an ab

US‑registered devices77in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Boston Scientific Corporation2532%
St. Jude Medical, Inc.2330%
Medtronic, Inc.2026%
Biotronik Se & Co. Kg56%
Microport Crm Srl45%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation2532%
St. Jude Medical, Inc.2330%
Medtronic, Inc.2026%
Biotronik Se & Co. Kg56%
Microport Crm Srl45%

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

Brand names on the register (sample)

Zenex MRI™ENDURITY MRI™Assurity MRI™Assurity™Endurity™Sustain™Accent®Accent™Zephyr™Zephyr®Verity™Victory™Victory®Identity®Identity™Amvia Sky DR-T

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

FDA product codes

CodeNameDevices
NVZPulse generator, permanent, implantable84
LWPImplantable pulse generator, pacemaker (non-CRT)81
DXYimplantable pacemaker Pulse-generator15
NVNDrug eluting permanent right ventricular (RV) or right atria6
DXYImplantable Pacemaker Pulse-Generator2

GMDN & GCC registration

  • GMDN code 47265 · 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

Total Volume (Milliliter) · 22

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

How many dual-chamber implantable pacemaker, rate-responsive products are registered in the US?

77 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dual-chamber implantable pacemaker, rate-responsive", from 5 companies. The largest labeler is Boston Scientific Corporation with 32% of records.

Which FDA product codes apply?

NVZ (Pulse generator, permanent, implantable), LWP (Implantable pulse generator, pacemaker (non-CRT)), DXY (implantable pacemaker Pulse-generator), NVN (Drug eluting permanent right ventricular (RV) or right atria)

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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