PMA P010032S036

Device
EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S036
Product code
LGW
Decision date
2011-02-11
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
APPROVAL FOR ADDING HEAT SHRINK TUBING (HST) TO THE CONDUCTORS OF THE COAXIAL CABLE OF THE CHARGING ANTENNA WHICH IS USED WITH THE EON IPG SYSTEM.

Current openFDA PMA Record#

Device
EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S036
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2011-02-11
Decision code
APPR
Date received
2010-11-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR ADDING HEAT SHRINK TUBING (HST) TO THE CONDUCTORS OF THE COAXIAL CABLE OF THE CHARGING ANTENNA WHICH IS USED WITH THE EON IPG SYSTEM.