PMA P010032S129
- Device
- Trim Change
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S129
- Product code
- LGW
- Decision date
- 2017-06-28
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Software update to the Automated Test Equipment (ATE) that will set the value of Open Threshold and Switch Threshold for all Proclaim, Infinity, and Proclaim DRG devices to a constant value of 253 during manufacturing instead of calculating the trim value using a formula.
Current openFDA PMA Record#
- Device
- Trim Change
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S129
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-06-28
- Decision code
- OK30
- Date received
- 2017-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Software update to the Automated Test Equipment (ATE) that will set the value of Open Threshold and Switch Threshold for all Proclaim, Infinity, and Proclaim DRG devices to a constant value of 253 during manufacturing instead of calculating the trim value using a formula.