LWS · Implantable Cardioverter Defibrillator (Non-Crt)
· Class 3
Overview
| Product Code | LWS |
|---|---|
| Device Name | Implantable Cardioverter Defibrillator (Non-Crt) |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220012 | Aurora EV-ICD System | Medtronic, Inc. | Oct 20, 2023 | APPR |
| P110042 | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM | Boston Scientific Corporation | Sep 28, 2012 | APPR |
| P980050 | MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF | Medtronic, Inc. | Jun 14, 2000 | APPR |
| P980023 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | Biotronik, Inc. | Oct 27, 1998 | APPR |
| P980016 | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | Medtronic Cardiac Rhythm Disease Management | Oct 9, 1998 | APPR |
| P970024 | ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. | MicroPort CRM USA, Inc. | Aug 19, 1998 | APWD |
| P960040 | VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM | Boston Scientific | Jul 18, 1997 | APPR |
| P940024 | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. | Telectronics Pacing Systems, Inc. | Jul 3, 1997 | APPR |
| P950022 | TVL(TM) LEAD SYSTEM | ABBOTT MEDICAL | May 10, 1996 | APPR |
| P940008 | RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS | Boston Scientific | Nov 28, 1995 | APWD |
| P930035 | VENTAK(R) P2 SYSTEM | Boston Scientific | Mar 10, 1995 | APPR |
| P910077 | VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR | Boston Scientific | Jun 17, 1994 | APPR |
| P910073 | ENDOTAK LEAD SYSTEM | Boston Scientific | Aug 26, 1993 | APPR |
| P910023 | CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM | ABBOTT MEDICAL | Apr 30, 1993 | APPR |
| P900061 | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | Medtronic Cardiac Rhythm Disease Management | Feb 11, 1993 | APPR |
| P890061 | VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE | Boston Scientific | May 2, 1991 | APPR |
| P830060 | VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS | Boston Scientific | Oct 4, 1985 | APPR |
Top Applicants
- Boston Scientific — 7 clearances
- ABBOTT MEDICAL — 2 clearances
- Medtronic Cardiac Rhythm Disease Management — 2 clearances
- Medtronic, Inc. — 2 clearances
- Biotronik, Inc. — 1 clearance
