CRT C4TR01 CONSULTA CRT-P US MR

CRT C4TR01 CONSULTA CRT
Consulta® CRT-P - C4TR01

A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NVZ

Device Name: Pulse Generator, Permanent, Implantable

Device Class: 3

Physical State: A hermetically sealed outer can (usually metallic) houses electronic circuitry and allows for connection to pacing leads (electrodes).

Definition: Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Used as part of a pacing system that consists of a pulse generator and a lead, and which may also require an external pacemaker programmer.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Implanted in the chest or abdomen, and makes contact with cardiac tissue via pacing leads.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: NKE

Device Name: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Device Class: 3

Physical State: These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

Definition: These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00613994713667

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