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Device Explorer · FDA GUDID · GMDN 35852

Single-chamber implantable defibrillator

An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pa

US‑registered devices86in 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 Corporation2630%
Biotronik Se & Co. Kg2327%
St. Jude Medical, Inc.2226%
Medtronic, Inc.1113%
Microport Crm Srl45%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation2630%
Biotronik Se & Co. Kg2327%
St. Jude Medical, Inc.2226%
Medtronic, Inc.1113%
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)

Gallant™Entrant™Fortify Assura™Ellipse™FORTIFY™Current™Current®Rivacor Aura VR-T DXRivacor Rise VR-TRivacor Rise VR-T DXRivacor Aura VR-TActicor Sky VR-TActicor Sky VR-T DXRivacor Sky VR-TRivacor Sky VR-T DXRivacor 3 VR-T DF4 ProMRI

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

FDA product codes

CodeNameDevices
LWSImplantable cardioverter defibrillator (non-CRT)149
NVZPulse generator, permanent, implantable55
LWPImplantable pulse generator, pacemaker (non-CRT)6
NIKDefibrillator, automatic implantable cardioverter, with card6
MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER4
OSRPacemaker/icd/crt non-implanted components2

GMDN & GCC registration

  • GMDN code 35852 · 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) · 23

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

How many single-chamber implantable defibrillator products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Single-chamber implantable defibrillator", from 5 companies. The largest labeler is Boston Scientific Corporation with 30% of records.

Which FDA product codes apply?

LWS (Implantable cardioverter defibrillator (non-CRT)), NVZ (Pulse generator, permanent, implantable), LWP (Implantable pulse generator, pacemaker (non-CRT)), NIK (Defibrillator, automatic implantable cardioverter, with card)

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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