MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY
FDA premarket approval P010031/S018 · decided 2005-04-08
Approval details
- PMA number
- P010031
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INSYNC III MARQUIS,MAXIMO & SENTRY
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-11-16
- Decision date
- 2005-04-08
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC INSYNC III MARQUIS MODEL 7279 WITH MODEL 9989 APPLICATION SOFTWARE, MEDTRONIC INSYNC MAXIMO MODELS 7303 AND 7304 WITH MODEL 9998 APPLICATION SOFTWARE, MEDTRONIC INSYNC SENTRY MODELS 7297 AND 7299 WITH MODEL 9998 APPLICATION SOFTWARE. THE DEVICES ARE INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. THIS SYSTEM IS ALSO INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERAT
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