PRGMR 3037 INTERSTIM PATIENT SW UPDATE

PRGMR 3037 INTERSTIM PATIENT SW UPDATE
InterStim iCon - 3037

A portable, battery-powered external device intended to change, noninvasively, one or more of the operating parameters (the programs) of an implanted incontinence-control electrical stimulation system pulse generator. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provides historic and/or current information regarding the performance of the implant.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: EZW

Device Name: Stimulator, Electrical, Implantable, For Incontinence

Device Class: 3

Physical State: N/A

Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

Submission Type ID: 2

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: Y

Target Area: N/A

Regulation Number: 876.5270

Third Party Flag: N

Medical Specialty: GU

Code: QON

Device Name: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Device Class: 3

Physical State: Receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body

Definition: Treatment of chronic fecal incontinence

Submission Type ID: 2

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Electrical stimulation of the sacral nerve

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Sacral nerve, bladder, urinary and anal sphincters, pelvic floor, and rectosigmoid colon

Regulation Number: 876.5270

Third Party Flag: N

Medical Specialty: GU

Device Id: 00613994572059

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