ITREL SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S311 · decided 2018-04-26
Approval details
- PMA number
- P840001
- Supplement
- S311
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-08-28
- Decision date
- 2018-04-26
- Days to decision
- 972 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for the removal of the Parylene Coating from Itrel 4 Implantable Neurostimulators Models 37703 and 37704
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |