PMA P010032S118
- Device
- SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S118
- Product code
- LGW
- Decision date
- 2016-11-28
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664 Proclaim DRG IPG7108 Port PlugMN15000 Tunneling Tool KitNot applicable Torque WrenchNot applicable Pocket SizerMN10450-50 Implant Lead Kit, 50cmMN10450-50A Implant Lead Kit, SlimTip, 50cmNot applicable Soft Tissue AnchorMN12050 Lead Accessory Kit3874 St. Jude Medical Clinician Programmer App3875 St. Jude Medical Patient Controller App
Current openFDA PMA Record#
- Device
- SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S118
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-11-28
- Decision code
- APPR
- Date received
- 2016-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664 Proclaim DRG IPG7108 Port PlugMN15000 Tunneling Tool KitNot applicable Torque WrenchNot applicable Pocket SizerMN10450-50 Implant Lead Kit, 50cmMN10450-50A Implant Lead Kit, SlimTip, 50cmNot applicable Soft Tissue AnchorMN12050 Lead Accessory Kit3874 St. Jude Medical Clinician Programmer App3875 St. Jude Medical Patient Controller App