PMA P010032S176
- Device
- Proclaim SCS Neurostimulation System
- Applicant
- ABBOTT MEDICAL
- Product code
- LGW
- Decision date
- 2021-11-17
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for expanded magnetic resonance (MR) Conditional labeling for the Octrode 60cm Lead when implanted with the Proclaim XR IPGs (Models 3660 and 3662) and their associated accessories, including the port plug and lead anchors. This supplement requested expansion of the conditions of use within the MRI labeling to increase radiofrequency (RF) power limit from whole body SAR <=0.8 W/kg to normal operating mode (NOM) for scans using integrated body RF transmit coil with any receive coil, and also to expand implant locations eligible for MRI scans for lead tips in epidural space from T7 to T12 to C1 to S2.
Current openFDA PMA Record#
- Device
- Proclaim SCS Neurostimulation System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S176
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-11-17
- Decision code
- APPR
- Date received
- 2021-06-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanded magnetic resonance (MR) Conditional labeling for the Octrode 60cm Lead when implanted with the Proclaim XR IPGs (Models 3660 and 3662) and their associated accessories, including the port plug and lead anchors. This supplement requested expansion of the conditions of use within the MRI labeling to increase radiofrequency (RF) power limit from whole body SAR