MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
FDA premarket approval P980016/S054 · decided 2005-09-21
Approval details
- PMA number
- P980016
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-08-23
- Decision date
- 2005-09-21
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A FIRMWARE UPGRADE OF THE BATTERYCHECK MONITOR WHICH WILL IMPROVE TELEMETRY COMMUNICATION WITH THE IMPLANTED DEVICE.
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