Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
FDA premarket approval P840001/S533 · decided 2022-11-22
Approval details
- PMA number
- P840001
- Supplement
- S533
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris®
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-11-14
- Decision date
- 2022-11-22
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Separation of a manufacturing process, Bond Pad Array (EPA) Lid Removal, as a standalone process for better tracking at internal supplier Medtronic Tempe Campus (MTC); and the addition of a videoscope manufacturing equipment for improved process controls.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |