ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
FDA premarket approval P840001/S324 · decided 2016-03-30
Approval details
- PMA number
- P840001
- Supplement
- S324
- 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
- 2016-02-29
- Decision date
- 2016-03-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Acceptance of a new peel test monitoring process for blister trays and new peel tester equipment for the impacted products, as well as process parameter changes and other minor process updates for the package sealing, tray cleaning, and packaging inspection processes at the Rice Creek Facility.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |