MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR
FDA premarket approval P980016/S046 · decided 2005-06-14
Approval details
- PMA number
- P980016
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWAR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-01-12
- Decision date
- 2005-06-14
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC ENTRUST MODELS D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND THE MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT ARE INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE ENTRUST MODELS D153DRG, D153VRC AND D154 DRG ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIF
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