Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Basic Information
- Device Name
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Trade Name
- FRONTIER/FRONTIER II FAMILY OF CRT-PS
- PMA Number
- P030035
- Supplement Number
- S028
- Device Class
- FDA Class 3
- Product Code
- NKE
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 7, 2007
- Date Received
- April 6, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING: ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.
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 |
|---|---|---|---|
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA class 3 | Unknown |