Consulting Wallah › Device Explorer › Cardiovascular › Single-chamber implantable pacemaker, rate-respons
Device Explorer · FDA GUDID · GMDN 47267

Single-chamber implantable pacemaker, rate-responsive

A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate a

US‑registered devices54in 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

St. Jude Medical, Inc.1731%
Boston Scientific Corporation1528%
Medtronic, Inc.1426%
Biotronik Se & Co. Kg47%
Microport Crm Srl47%

Top labelers

CompanyDevicesShare
St. Jude Medical, Inc.1731%
Boston Scientific Corporation1528%
Medtronic, Inc.1426%
Biotronik Se & Co. Kg47%
Microport Crm Srl47%

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™Zephyr™Zephyr®Identity®Verity™Verity®Microny™Amvia Sky SR-TAmvia Edge SR-TSolvia Rise SR-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, implantable58
LWPImplantable pulse generator, pacemaker (non-CRT)48
NVNDrug eluting permanent right ventricular (RV) or right atria10
KRGProgrammer, pacemaker7
DXYImplantable Pacemaker Pulse-Generator2
LWOPulse-generator, single chamber, sensor driven, implantable1

GMDN & GCC registration

  • GMDN code 47267 · 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) · 15

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

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

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Single-chamber implantable pacemaker, rate-responsive", from 5 companies. The largest labeler is St. Jude Medical, Inc. with 31% of records.

Which FDA product codes apply?

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

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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