GENERATOR RDNG3A G3SV5.1 US JP CA

GENERATOR RDNG3A G3SV5.1 US JP CA
Symplicity G3™ - RDNG3A

An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QYI

Device Name: Ablation Catheter, Renal Denervation

Device Class: 3

Physical State: Catheter and generator

Definition: For denervating the renal nerves to lower blood pressure

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Catheter delivered near the renal nerves to deliver energy to cause denervation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Renal vasculature and nerves

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000387020

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