Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System
FDA premarket approval P210037/S007 · decided 2024-06-28
Approval details
- PMA number
- P210037
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2024-05-29
- Decision date
- 2024-06-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- to add a new laser structuring machine for the manufacturing of the Prospera implantable pulse generator
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.