ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
FDA premarket approval P840001/S067 · decided 2003-05-09
Approval details
- PMA number
- P840001
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2003-03-24
- Decision date
- 2003-05-09
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE SNAP LID SCREENING CABLE, THE OCTAD PERCUTANEOUS EXTENSION AND THE OCTAD STYLET WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |