Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
FDA premarket approval P840001/S489 · decided 2021-08-25
Approval details
- PMA number
- P840001
- Supplement
- S489
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-05-27
- Decision date
- 2021-08-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for 1) design changes to add an alternative glassed feedthrough assembly component which has the same fit, form and function, to the current brazed feedthrough assembly component in the Model 97715 and Model 97716 Intellis Implantable Neurostimulators, and 2) manufacturing changes to include a new chemical treatment step (i.e., Nitric/HF acid) to clean the titanium array plate (A distilled water rinse step will be added after the new chemical treatment step to remove any residual chemic
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |