MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR
FDA premarket approval P840001/S058 · decided 2001-12-14
Approval details
- PMA number
- P840001
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2001-10-22
- Decision date
- 2001-12-14
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 7427V SYNERGY VERSITREL DUAL CHANNEL IMPLANTABLE PULSE GENERATOR AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTACTABLE 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 |