IPG SEDR01 SENSIA US MKT

IPG SEDR01 SENSIA US MKT
Sensia® - SEDR01

A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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

Device Id: 00643169474253

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