Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Basic Information
- Device Name
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Trade Name
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- PMA Number
- P030054
- Supplement Number
- S238
- Device Class
- FDA Class 3
- Product Code
- NIK
- Generic Name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 6, 2013
- Date Received
- November 14, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
PPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | FDA class 3 | Unknown |