ITREL 3 SYNERGY AND SYNERGY VERITREL SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S073 · decided 2004-06-16
Approval details
- PMA number
- P840001
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL 3 SYNERGY AND SYNERGY VERITREL SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2004-05-19
- Decision date
- 2004-06-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A NEW PERMANENTLY IMPLANTED SURGICAL LEAD (MODEL 3999 HINGED 2 X 4 LEAD) TO BE USED WITH MEDTRONICS FULLY IMPLANTABLE NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (P840001) OR THE EXTERNAL RADIO FREQUENCY NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (K934065).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |