RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATOR SYSTEMS
FDA premarket approval P840001/S096 · decided 2007-06-11
Approval details
- PMA number
- P840001
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATOR SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2007-03-23
- Decision date
- 2007-06-11
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 39565 SPECIFY 5-6-5 LEAD KIT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |