ICD-DR DDMD3D4 PRIMO MRI US

ICD
Primo MRI™ DR SureScan™ - DDMD3D4

A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; 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: 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: 00763000001513

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