MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS
FDA premarket approval P010031/S028 · decided 2005-11-15
Approval details
- PMA number
- P010031
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-10-05
- Decision date
- 2005-11-15
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK.
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