ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
FDA premarket approval P840001/S211 · decided 2012-05-30
Approval details
- PMA number
- P840001
- Supplement
- S211
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-04-05
- Decision date
- 2012-05-30
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704 AND ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OFTHE TRUNK AND/OR LIMBS-INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS: 1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY T
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |