FDA Approved
Existing Device (Modification)
Pathway: PMA
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable B35200)
Applicant:
Medtronic, Inc.
MDT
Statutory Profile
Legal Standard:
Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)
Product Code:
MHY
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:
Identified Contacts & Correspondents
Marsha Seetaram
Role: US_AGENT
📞 904-2812763
✉️ marsha.n.seetaram@medtronic.com
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