Intellis Spinal Cord Stimulation Systems; Specify and Vectris Spinal Cord Stimulation Leads; Injex lead anchors
FDA premarket approval P840001/S480 · decided 2021-03-05
Approval details
- PMA number
- P840001
- Supplement
- S480
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Intellis Spinal Cord Stimulation Systems; Specify and Vectris Spinal Cord Stimulation Leads; Injex lead anchors
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-12-07
- Decision date
- 2021-03-05
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an update to the Clinical Summary manual for Medtronic Spinal Cord Stimulation (SCS) Therapy to include data from a post-market randomized controlled trial (RCT) entitled Stimgenics Open-Label, Post Market Study: A Clinical Trial to Study the Effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) Programs in Treating Intractable Chronic Back Pain. There are no changes to indications for use, procedures or devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |