PROGRAMMER 29901 CARELINK ENCORE US

PROGRAMMER 29901 CARELINK ENCORE US
CareLink Encore™ - 29901

An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DXY

Device Name: Implantable Pacemaker Pulse-Generator

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3610

Third Party Flag: N

Medical Specialty: CV

Code: LWP

Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)

Device Class: 3

Physical State: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Definition: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: KRG

Device Name: Programmer, Pacemaker

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.3700

Third Party Flag: N

Medical Specialty: CV

Code: OSR

Device Name: Pacemaker/Icd/Crt Non-Implanted Components

Device Class: 3

Physical State: Pacemaker/ICD/CRT non-implanted components can be separate pieces or integrated and usually include housings, electronics, processors, software, connectors, and cables.

Definition: Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Pacemaker/ICD/CRT non-implanted components transmit data from the implanted device to the health care provider using telemetry download, and direct or remote transmission.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Pacemaker/ICD/CRT devices are intended to provide therapy to the heart. The non-implanted components support the implanted devices.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

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: 00613994909688

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