ACC 7440 ISTIM PROG ANT23.0LG
NA - 7440
Device Description
An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.
Environmental Conditions
- 57.00
- -34.00
- 135.00
- -30.00
Device Sizes
- Length: 23.0 Inch
- Length: 58.0 Centimeter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: LGW
Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: NE
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: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 10681490164594
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