ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
FDA premarket approval P840001/S321 · decided 2016-04-21
Approval details
- PMA number
- P840001
- Supplement
- S321
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-02-08
- Decision date
- 2016-04-21
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Decla
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |