NIK · Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
· Class 3
Overview
| Product Code | NIK |
|---|---|
| Device Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P060027 | OVATIO CRT SYSTEM | MicroPort CRM USA, Inc. | May 15, 2008 | APPR |
| P030054 | ST JUDE MEDICAL EPIC HF SYSTEM | ABBOTT MEDICAL | Jun 30, 2004 | APPR |
| P010031 | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | Medtronic Cardiac Rhythm Disease Management | Jun 26, 2002 | APPR |
| P010012 | CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL | Boston Scientific Corp | May 2, 2002 | APPR |
Top Applicants
- ABBOTT MEDICAL — 1 clearance
- Boston Scientific Corp — 1 clearance
- Medtronic Cardiac Rhythm Disease Management — 1 clearance
- MicroPort CRM USA, Inc. — 1 clearance
