Pulse Generator, Permanent, Implantable
Basic Information
- Device Name
- Pulse Generator, Permanent, Implantable
- Trade Name
- MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER
- PMA Number
- P890003
- Supplement Number
- S141
- Device Class
- FDA Class 3
- Product Code
- NVZ
- Generic Name
- Pulse generator, permanent, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 8, 2008
- Date Received
- June 13, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE CHANGES MADE TO THE MODEL 2490G MEDTRONIC CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AS FOLLOWS: 1) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE REVEAL XT AND REVEAL DX TO THE MODEL 2490G CARELINK MONITOR.2) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR TO ALLOW THE MONITOR TO FACILITATE RESETTING FIVE OF THE EIGHT NOTIFICATIONS OF THE MODEL 9529 REVEAL XT USED IN CONJUNCTION WITH THE MODEL 9539 REVEAL PATIENT ASSISTANT.3) UPDATED FIRMWARE IN THE MODEL 2490G CARELINK MONITOR AS A PREVENTATIVE MEASURE, TO RESOLVE AN INCONSISTENCY WHICH COULD POTENTIALLY CAUSE AN INVALID CARELINK TRANSMISSION TO BE SENT TO THE CARELINK NETWORK. 4) UPDATED THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) TO SUPPORT THE MODEL 9529 REVEAL XT AND THE MODEL 9528 REVEAL DX INSERTABLE CARDIAC MONITORS.
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 |
|---|---|---|---|
| NVZ | Pulse Generator, Permanent, Implantable | FDA class 3 | Unknown |