Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock
FDA premarket approval P210037/S013 · decided 2025-10-23
Approval details
- PMA number
- P210037
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2025-09-23
- Decision date
- 2025-10-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for an alternative supplier, Unisteel, for the set screw component used to fix the connector pin of an inserted lead in the ports of the Prospera IPG (Part Number 338566)
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