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CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol

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Generic:Implantable pulse generator, pacemaker (non-CRT)
Manufacturer:medtronic inc.
Drug Classes:Not Available
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CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol

Generic:Implantable pulse generator, pacemaker (non-CRT)
Manufacturer:medtronic inc.
Drug Classes:Not Available
Reps:
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Synopsis
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Indication and Usage
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Synopsis
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CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
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Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Indication and Usage

THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS: 1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION = 130 MS. 2) THE ATTAIN LV MODEL 2187 LEAD HAS APPLICATION AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM. 3) THE ATTAIN CS MODEL 2188 LEAD HAS APPLICATION WHERE PERMANENT ATRIAL, OR FUAL-CHAMBER PACING SYSTEMS ARE INDICATED, OR AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.

Approval History
FDA approved 2020
Includes history for all formulations of adalimumab
May 17, 2020
(Type 2 New Active Ingredient and Type 4 New Combination)
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