Master Restore, Itrel, and Intellis Spinal Cord Stimulation Systems
FDA premarket approval P840001/S386 · decided 2017-12-12
Approval details
- PMA number
- P840001
- Supplement
- S386
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel, and Intellis Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-11-20
- Decision date
- 2017-12-12
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Manufacturing process change at a 2nd-tier supplier of capacitors used in the manufacture of hybrids contained in Medtronic implantable neurostimulators.
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 |