Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock
FDA premarket approval P210037/S008 · decided 2024-07-01
Approval details
- PMA number
- P210037
- Supplement
- S008
- 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
- 2024-06-06
- Decision date
- 2024-07-01
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- new bioburden specifications for currently used class C and D cleanrooms at BIOTRONIK SE & Co. KG in Berlin for the Prospera SCS System
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