Master Restore, Itrel®, Synergy® and IntellisTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Sp
FDA premarket approval P840001/S501 · decided 2022-03-16
Approval details
- PMA number
- P840001
- Supplement
- S501
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel®, Synergy® and IntellisTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Sp
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-09-08
- Decision date
- 2022-03-16
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the replacement of degreasing equipment and use of a new degreasing solvent.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |