FDA Approved
Existing Device (Modification)
Pathway: PMA
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify,
Applicant:
Medtronic Neuromodulation
MDT
Statutory Profile
Legal Standard:
Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)
Product Code:
LGW
Review Panel:
Neurology
21 CFR Regulation:
Unspecified
Review Velocity Metrics
Date Received:
2026-09-30
Decision Date:
2026-10-29
Total Review Duration:
29 calendar days (29 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
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