PMA P010032S067
- Device
- TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S067
- Product code
- LGW
- Decision date
- 2013-10-15
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL TO INCREASE THE UPPER LIMIT OF THE GROOVE WIDTH AND DEPTH ON THE PENTA ELECTRODE.
Current openFDA PMA Record#
- Device
- TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S067
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-10-15
- Decision code
- APPR
- Date received
- 2013-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INCREASE THE UPPER LIMIT OF THE GROOVE WIDTH AND DEPTH ON THE PENTA ELECTRODE.