ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
FDA premarket approval P840001/S323 · decided 2016-03-08
Approval details
- PMA number
- P840001
- Supplement
- S323
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2016-02-12
- Decision date
- 2016-03-08
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Changes to test sample sizes and control limits, changes to the surface treatment and cleaning processes of metal subcomponents, and transfer of receiving and incoming inspection activities for device components to alternate facilities used in the manufacture of SCS lead kits.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |