A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a
| Company | Devices | Share |
|---|---|---|
| Boston Scientific Corporation | 31 | 38% |
| St. Jude Medical, Inc. | 22 | 27% |
| Biotronik Se & Co. Kg | 12 | 15% |
| Medtronic, Inc. | 12 | 15% |
| Microport Crm Srl | 4 | 5% |
Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | 76 |
| NVZ | Pulse generator, permanent, implantable | 56 |
| MRM | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER | 42 |
| LWP | Implantable pulse generator, pacemaker (non-CRT) | 13 |
| NIK | Defibrillator, automatic implantable cardioverter, with card | 8 |
| OSR | Pacemaker/icd/crt non-implanted components | 2 |
Use these as the dimensions to specify in a tender line.
81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dual-chamber implantable defibrillator", from 5 companies. The largest labeler is Boston Scientific Corporation with 38% of records.
LWS (Implantable cardioverter defibrillator (non-CRT)), NVZ (Pulse generator, permanent, implantable), MRM (DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER), LWP (Implantable pulse generator, pacemaker (non-CRT))
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.