Gem Model 7227 Implantable Cardioverter Defibrillator
by Medtronic Cardiac Rhythm Disease Management PMA
Active
PMA P900061
Overview
The Gem Model 7227 is an Implantable Cardioverter Defibrillator (Non-CRT), a Class III medical device designed to monitor heart rhythms and deliver electrical therapy to terminate life-threatening ventricular tachyarrhythmias, including ventricular fibrillation and ventricular tachycardia. It is intended for patients at risk of sudden cardiac death due to these arrhythmias, providing automatic detection and response to restore a normal heart rhythm.
This device is supplied as a reusable system component, intended for implantation by qualified healthcare professionals in clinical settings such as hospitals or cardiac electrophysiology labs. It requires sterile handling during implantation and is regulated under an FDA Premarket Approval (PMA) with PMA number P900061. The device operates within MRI-safe parameters as defined by its specifications and is distributed under the product code LWS.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900061 | Date11 Feb 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Gem Model 7227 Icd
- Trade Name
- Medtronic Pcd Tachyarrhythmia Control System
- Generic Name
- Implantable cardioverter defibrillator (non-CRT)
- PMA Number
- FDA Product Code
- LWS
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
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Questions
What is the primary purpose of the Gem Model 7227 ICD, and who is it designed for?
The Gem Model 7227 is an Implantable Cardioverter Defibrillator (Non-CRT) designed to monitor heart rhythms and deliver electrical therapy to treat life-threatening ventricular tachyarrhythmias, such as ventricular fibrillation and ventricular tachycardia. It is intended for patients at risk of sudden cardiac death due to these arrhythmias, providing automatic detection and therapy to restore a normal heart rhythm.
Is the Gem Model 7227 ICD intended for single-use or can it be reused?
The Gem Model 7227 ICD is supplied as a reusable system component, meaning it is intended for implantation by qualified healthcare professionals in clinical settings like hospitals or cardiac electrophysiology labs. It is not a single-use device, but sterile handling is required during the implantation process.
What regulatory pathway does the Gem Model 7227 ICD follow, and what is its product code?
The Gem Model 7227 ICD follows the FDA Premarket Approval (PMA) pathway, with the PMA number P900061. It is categorized under product code LWS in the FDA’s regulatory system.
Can this device be used in patients who require MRI scans, and how is it distributed?
The Gem Model 7227 ICD operates within MRI-safe parameters as defined by its specifications, allowing for use in patients who may require MRI scans. It is distributed by Medtronic Cardiac Rhythm Disease Management under the trade name *MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM* and is available through authorized healthcare providers.