TPS MC1VR01US MICRA US SCALABLE

TPS MC1VR01US MICRA US SCALABLE
Micra™ - MC1VR01US

A battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included.

• Catheter Size 23 French
• Length: 105.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PNJ

Device Name: Leadless Pacemaker

Device Class: 3

Physical State: TBD

Definition: To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: TBD

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: TBD

Regulation Number: 870.3610

Third Party Flag: N

Medical Specialty: CV

Device Id: 00643169711761

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