RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS
FDA premarket approval P840001/S352 · decided 2017-02-07
Approval details
- PMA number
- P840001
- Supplement
- S352
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-01-13
- Decision date
- 2017-02-07
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for labeling changes which identify new potential adverse reactions, improve instructions for avoiding device inversion, and update radiation safety labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |