PMA P010032S055

Device: EON NEUROSTIMULATION SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S055
Product code: LGW
Decision date: 2012-10-25
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY.

Current openFDA PMA Record#

Device: EON NEUROSTIMULATION SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S055
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2012-10-25
Decision code: APPR
Date received: 2012-06-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY.