Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S
FDA premarket approval P840001/S576 · decided 2024-11-05
Approval details
- PMA number
- P840001
- Supplement
- S576
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-10-10
- Decision date
- 2024-11-05
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval of the use of a new termination paste that is used for the discoidal capacitor (a ceramic capacitor) which is used in the Restore sensor and Restore ultra products at Medtronic Energy and Component Center (Located in Brooklyn Center, MN)
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 |