Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
FDA premarket approval P840001/S487 · decided 2021-05-06
Approval details
- PMA number
- P840001
- Supplement
- S487
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-04-09
- Decision date
- 2021-05-06
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Use of an alternate component supplier Meier Tool & Engineering, Inc. for the platinum iridium electrodes used in SCS Leads, Models 39286, 39565, 977C165, 977C190, 977C265, & 977C290. Meier Tool & Engineering, Inc. will form the electrodes using progressive die instead of manual blank/form die. Vanishing Oil 101 will be used in the manufacturing process. Meier Tool & Engineering, Inc. will SQM Inspect the product and Medtronic Villalba will SQM Verify the product.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |