ITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
FDA premarket approval P840001/S068 · decided 2003-05-09
Approval details
- PMA number
- P840001
- Supplement
- S068
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2003-04-07
- Decision date
- 2003-05-09
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO PISCES Z QUAD LEAD TECHNICAL MANUALS AND A CHANGE TO THE NEEDLE IN THE PISCES Z QUAD LEAD KITS AND IN THE MODEL 3550-22 AND MODEL 3550-23 ACCESSORY KITS FROM 15 GAUGE TO THE 14 GAUGE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |