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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceProspera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBiotronik NRO, Inc.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP210037
Date Received12/02/2021
Decision Date03/31/2023
Product Code LGW 
Docket Number 23M-1260
Notice Date 04/05/2023
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S007 S008 
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