Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
FDA premarket approval P840001/S427 · decided 2020-07-01
Approval details
- PMA number
- P840001
- Supplement
- S427
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-03-25
- Decision date
- 2020-07-01
- Days to decision
- 464 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an update to the drawing for the Carrier-Electrode Plate, 5-6-5, Medtronic Part Number M926542A001, as a result of a molding manufacturing process change at the supplier, which included, but was not limited to, a change for manufacturing the carrier from a Silicone Molding process to a Liquid Injection Molding process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |