Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
FDA premarket approval P840001/S488 · decided 2021-08-12
Approval details
- PMA number
- P840001
- Supplement
- S488
- 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
- 2021-05-17
- Decision date
- 2021-08-12
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a design change to the Recharger Therapy Manager (RTM) model 97755, to modify the interface between the antenna and the cable, to include an additional strain relief. This strain relief at the antenna-cable interface will include an elongated antenna section that is overmolded with a strain relief at the antenna-cable interface. Additionally, RTM cable length specification changes from 37 ± 1 inches to 35.4 ± 2 inches and the Crimp Ferrule minimum pull force strength will be increas
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |