- Device
- Proclaim™ Dorsal Root Ganglion (DRG) IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S079
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2025-01-13
- Decision code
- APPR
- Date received
- 2024-10-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware version 1.3 and OneApp version 4.1, which include an expanded impedance range and updated trim values used for Magnetic Resonance Imaging (MRI) Mode, updated Elective Replacement Indicator requirement for Orion IPG systems, and labeling updates to account for these changes. You are also proposing to add a check for the MR conditional status of the combination of leads and Implanted Pulse Generators before entering MRI Mode, specify spinal cord stimulation therapy type for two MR Conditional leads (Models 3292 & 3219), define six legacy leads in the OneApp code, and add a program validation check during a Virtual Clinic session to OneApp