LEAD 4351-35 ENTERRA GASTRIC EMAN FWU

LEAD 4351
ENTERRA ™ - 4351-35

An assembly of devices designed to treat chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis through gastric electrical stimulation (GES) of the lower stomach (antrum). The assembly typically includes a battery-powered implantable pulse generator that produces the electrical stimuli delivered via implantable leads, and an external programmer that enables healthcare personnel to telemetrically modify the GES signal parameters of the pulse generator.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LNQ

Device Name: Intestinal Stimulator

Device Class: f

Physical State: N/A

Definition: N/A

Submission Type ID: 6

Review Panel: GU

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00643169887589

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