Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock
• Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
• Applicant: Biotronik Nro, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P210037
• Supplement Number: S005
• Date Received: 02/23/2024
• Decision Date: 06/13/2024
• Product Code: LGW
• Advisory Committee: Neurology
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for an update to the factory file used during the final manufacturing step to configure the BLE transmission power to +4 dBm.