Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr
FDA premarket approval P840001/S578 · decided 2024-11-18
Approval details
- PMA number
- P840001
- Supplement
- S578
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-10-23
- Decision date
- 2024-11-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- the addition of Integer as an alternate supplier for the Titanium Shield Assembly component for the Medtronic Pain RC Implantable Neurostimulators (Models 97717, 97718, and 97719) and the incorporation of a related manufacturing process change to add an edge break
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 |