PMA P960009S543

Device
INS PERCEPT RC Vl Deep Brain Stimulation (DBS) Implantable Neurostimulators, Percept ™ PC BrainSense TM Implantable Neur
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S543
Product code
MHY
Decision date
2026-08-21
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
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Current openFDA PMA Record#

Device
INS PERCEPT RC Vl Deep Brain Stimulation (DBS) Implantable Neurostimulators, Percept ™ PC BrainSense TM Implantable Neur
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S543
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2026-08-21
Decision code
OK30
Date received
2026-07-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
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