Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Basic Information
- Device Name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Trade Name
- Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
- PMA Number
- P210037
- Device Class
- FDA Class 3
- Product Code
- LGW
- Generic Name
- Stimulator, spinal-cord, totally implanted for pain relief
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 31, 2023
- Date Received
- December 2, 2021
- Expedited Review
- N
- Docket Number
- 23M-1260
Advisory Committee Statement
Approval for the Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management. The Indications for Use (IFU) of the device is as follows:The Prospera spinal cord stimulation (SCS) system is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain, resulting from any of the following: 1) Failed Back Syndrome (FBS) or low back syndrome or failed back; 2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or; 3) herniated disk; 4) Postlaminectomy pain; 5) Multiple back operations; 6) Unsuccessful disk surgery; 7) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and; 8) surgical interventions; 9) Peripheral causalgia;10) Epidural fibrosis;11) Arachnoiditis or lumbar adhesive arachnoiditis; and12) Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgiai.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | FDA class 3 | Unknown |