INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE
FDA premarket approval P010031/S005 · decided 2003-07-21
Approval details
- PMA number
- P010031
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-01-27
- Decision date
- 2003-07-21
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE INSYNC II MARQUIS MODEL 7289 WITH MODEL 9989 APPLICATION SOFTWARE. THE SYSTEM AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSYNC II MARQUIS AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THE SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SEVERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPIT
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