PMA P010032S152
- Device
- GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S152
- Product code
- LGW
- Decision date
- 2019-07-17
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Implement a manufacturing process change that changes the in-process electrode cleaning method for the S-Series Leads from one ultrasonic cleaning method to another.
Current openFDA PMA Record#
- Device
- GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S152
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-07-17
- Decision code
- OK30
- Date received
- 2019-06-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a manufacturing process change that changes the in-process electrode cleaning method for the S-Series Leads from one ultrasonic cleaning method to another.