Prospera SCS System
FDA premarket approval P210037/S001 · decided 2023-07-20
Approval details
- PMA number
- P210037
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prospera SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2023-06-22
- Decision date
- 2023-07-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Introduction of an imaging process system which automatically determines the offset for the start position a the laser seam welding process for the Prospera Implantable Pulse Generator (IPG).
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