Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Basic Information
- Device Name
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Trade Name
- VARIOUS FAMILIES OF CRT-ICD'S
- PMA Number
- P010031
- Supplement Number
- S068
- 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 14, 2007
- Date Received
- May 21, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR. THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS. THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT. FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR. THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBER CSX750VJB20.000MUT). 2) THERE ARE TWO CAPACITORS BEING CHANGED. THE CAPACITOR AT LOCATION C230 IS CHANGING FROM 3300 PF TO 6800 PF. THE CAPACITOR AT LOCATION C277 IS CHANGING FROM 470 PF TO 6800 PF. BOTH THE CURRENT CAPACITORS AND THE NEW CAPACITORS ARE PROVIDED BY THE SAME MANUFACTURER.
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 |