PMA P210037S017

Device: Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLock
Applicant: Biotronik Nro, Inc.
PMA number: P210037
Supplement: S017
Product code: LGW
Decision date: 2026-06-05
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for a new automated can closing process (i.e., laser seam welding, gas filling, bunghole closing, and mechanical check of leak rate) for Prospera IPGs.

Current openFDA PMA Record#

Device: Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLock
Applicant: Biotronik Nro, Inc.
PMA number: P210037
Supplement: S017
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-06-05
Decision code: OK30
Date received: 2026-05-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new automated can closing process (i.e., laser seam welding, gas filling, bunghole closing, and mechanical check of leak rate) for Prospera IPGs.