MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
FDA premarket approval P840001/S091 · decided 2006-02-08
Approval details
- PMA number
- P840001
- Supplement
- S091
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2006-01-20
- Decision date
- 2006-02-08
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR REVISED TEXT TO THE CAUTION IN THE "PLACING A PERCUTANEOUS LEAD" SECTION OF THE INSTRUCTIONS FOR USE SECTION OF THE FOLLOWING MANUALS: MODEL 3898 PISCES-OCTAD LEAD KIT IMPLANT MANUAL, MODEL 3487 A PISCES QUAD, MODEL 3887 PISCES QUAD COMPACT, AND MODEL 3888 PISCES QUAD PLUS LEAD KITS IMPLANT MANUAL, AND MODEL 3890 PISCES Z QUAD, MODEL 3891 PISCES Z QUAD COMPACT, AND MODEL 3892 PISCES Z QUAD PLUS LEAD KITS IMPLANT MANUAL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |