Restore and Itrel Spinal Cord Stimulation Systems
FDA premarket approval P840001/S358 · decided 2017-05-11
Approval details
- PMA number
- P840001
- Supplement
- S358
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore and Itrel Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-04-14
- Decision date
- 2017-05-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Notification of the intent to semi-automate the completion and confirmation of required packaging components and make changes to process steps in the final packaging assembly at Medtronic Puerto Rico Operations, Juncos.
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 |