PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE
FDA premarket approval P060027/S011 · decided 2009-10-27
Approval details
- PMA number
- P060027
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-02-20
- Decision date
- 2009-10-27
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE. THE DEVICE IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING ARRHYTHMIAS. THE DEVICE IS ALSO INDICATED FOR THE REDUCTION OF HEART FAILURE SYMPTOMS IN MEDICALLY OPTIMIZED NYHA FUNCTIONAL CLASS III AND IV PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION OF 35% OR LESS, AND A QRS DURATION OF 150 MS OR LONGER.
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