PMA P010032S038
- Device
- EON MINI NEUROSTIMULATION SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S038
- Product code
- LGW
- Decision date
- 2011-09-20
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL TO ADD AN ALTERNATE SUPPLIER FOR THE FEED THROUGH ASSEMBLY.
Current openFDA PMA Record#
- Device
- EON MINI NEUROSTIMULATION SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S038
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2011-09-20
- Decision code
- APPR
- Date received
- 2011-05-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD AN ALTERNATE SUPPLIER FOR THE FEED THROUGH ASSEMBLY.