PMA P010032S133
- Device
- Genesis And Eon Family Neurostimulation (IPG) Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S133
- Product code
- LGW
- Decision date
- 2017-09-06
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Updates to the sterilization equipment and bioburden test site.
Current openFDA PMA Record#
- Device
- Genesis And Eon Family Neurostimulation (IPG) Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S133
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-09-06
- Decision code
- OK30
- Date received
- 2017-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the sterilization equipment and bioburden test site.