ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS
FDA premarket approval P840001/S273 · decided 2014-12-05
Approval details
- PMA number
- P840001
- Supplement
- S273
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-06-19
- Decision date
- 2014-12-05
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE CHANGES TO THE PATIENT PROGRAMMER AND PATIENT RECHARGE KIT USED FOR MEDTRONIC SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
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 |