PMA P010032S066

Device
EON MINI IMPLANTABLE PULSE GENERATOR
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S066
Product code
LGW
Decision date
2013-03-15
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
APPROVAL FOR DESIGN CHANGES TO THE HEADER OF EON MINI IMPLANTABLEPULSE GENERATOR (IPG), MODEL 3788.

Current openFDA PMA Record#

Device
EON MINI IMPLANTABLE PULSE GENERATOR
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S066
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2013-03-15
Decision code
APPR
Date received
2012-12-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR DESIGN CHANGES TO THE HEADER OF EON MINI IMPLANTABLEPULSE GENERATOR (IPG), MODEL 3788.