ITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
FDA premarket approval P840001/S064 · decided 2002-09-26
Approval details
- PMA number
- P840001
- Supplement
- S064
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2002-06-24
- Decision date
- 2002-09-26
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 3890 PISCES Z QUAD LEAD, MODEL 3891 PISCES Z QUAD COMPACT LEAD, MODEL 3892 PISCES Z QUAD PLUS LEAD AND MODEL 3550-22 AND 3550-23 LEAD REVISION KITS. THE DEVICES 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 |