ICD D204VRM SECURA VR US MR DF4

ICD D204VRM SECURA VR US MR DF4
Secura® VR - D204VRM

An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NIK

Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Device Class: 3

Physical State: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Definition: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: LWS

Device Name: Implantable Cardioverter Defibrillator (Non-Crt)

Device Class: 3

Physical State: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Definition: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00613994714718

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A