Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Basic Information
- Device Name
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- Trade Name
- FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads)
- PMA Number
- P960004
- Supplement Number
- S085
- Device Class
- FDA Class 3
- Product Code
- NVN
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 27, 2018
- Date Received
- April 30, 2018
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.
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 |
|---|---|---|---|
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | FDA class 3 | Unknown |