PMA P010032S130
- Device
- Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S130
- Product code
- LGW
- Decision date
- 2017-07-21
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- 1) Add a St. Jude Medical Facility located in Plymouth, MN as an alternate supplier for the extrusion and manufacture of the outer tubing and spacer components of the leads, extensions, and adapters; 2) adjust tolerances due to tighter process controls; and 3) implement the use of a visual measurement system for inspection.
Current openFDA PMA Record#
- Device
- Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S130
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-07-21
- Decision code
- OK30
- Date received
- 2017-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- 1) Add a St. Jude Medical Facility located in Plymouth, MN as an alternate supplier for the extrusion and manufacture of the outer tubing and spacer components of the leads, extensions, and adapters; 2) adjust tolerances due to tighter process controls; and 3) implement the use of a visual measurement system for inspection.