PMA P010032S127
- Device
- LGW
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S127
- Product code
- LGW
- Decision date
- 2017-02-03
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for an updated version (v 3.4) of Clinician Programmer and Patient Controller software to enable the Surgery Mode and Device Status check feature in the Proclaim Elite, Infinity, and Proclaim DRG family of implanted pulse generators (IPGs).
Current openFDA PMA Record#
- Device
- LGW
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S127
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-02-03
- Decision code
- APPR
- Date received
- 2016-11-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an updated version (v 3.4) of Clinician Programmer and Patient Controller software to enable the Surgery Mode and Device Status check feature in the Proclaim Elite, Infinity, and Proclaim DRG family of implanted pulse generators (IPGs).