Identity
- Trade Name
- CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM FDA PMA
- Generic Name
- Implantable cardioverter defibrillator (non-CRT) FDA PMA
Identifiers
- PMA Number
- P910023 FDA PMA
- FDA Product Code
- LWS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Tendril STS 2088TC Lead is an implantable cardioverter defibrillator lead designed for use with the Cadence Tiered Therapy Defibrillator System. It is intended for patients with a history of hemodynamically compromising ventricular tachyarrhythmias, including those who have experienced cardiac arrest not associated with acute myocardial infarction or have ventricular tachyarrhythmias.
This lead is supplied as part of a system that includes defibrillation capabilities and may be used with Ventritex epicardial defibrillation leads, CPI defibrillation patch leads, and superior vena cava spring leads. The device is FDA PMA approved and is intended for use as a replacement for CPI automatic implantable cardioverter defibrillators when used with CPI patch leads or SVC leads.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910023 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P910023 24 fields · synced Sep 18, 2026