Permanent Defibrillator Electrodes
Basic Information
- Device Name
- Permanent Defibrillator Electrodes
- Trade Name
- 5076 CAPSUREFIX NOVUS SURESCAN LEADS
- PMA Number
- P930039
- Supplement Number
- S138
- Device Class
- FDA Class 3
- Product Code
- NVY
- Generic Name
- Permanent defibrillator electrodes
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 11, 2015
- Date Received
- March 16, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.
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 |
|---|---|---|---|
| NVY | Permanent Defibrillator Electrodes | FDA class 3 | Unknown |