PMA approvals

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger

ABBOTT MEDICAL · Stimulator, electrical, implanted, for parkinsonian tremor · Neurology

P140009 S142SupplementOK30
Open FDA's page for this record
PMA number
P140009
Supplement number
S142
Applicant
ABBOTT MEDICAL
Street 1
6901 Prestion Rd.
City
Plano
State
TX
Zip
75024
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Trade name
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger
Product code
MHY
Advisory committee
NE
Advisory committee description
Neurology
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-30
Decision date
2026-10-30
Decision code
OK30
Ao statement
qualification of an alternate Metal–Oxide–Semiconductor Field-Effect Transistor (MOSFET) electronic component and supplier
Harmonized identifiers (openFDA)
Device name
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medical specialty description
Unknown
Device class
3
Registration number
2133772, 1627487, 3010052483, 3018094310, 3009380063, 3015200795, 3010086866, 3003335547, 3003477135, 3003120897, 2135338, 3004593495, 3019807891, 2648729, 3038429246, 3006630150, 3004209178, 3010972758, 3005160949, 9616693, 3006705815, 2182207, 2133641, 2183744, 1928237, 2024311, 3010531069, 2649622, 3005210579, 2124215, 3015924373, 3013023969
FEI number
1627487, 3000203466, 3000209794, 3010052483, 3018094310, 3009380063, 3015200795, 3010086866, 3003335547, 3003477135, 3003120897, 3004593495, 3004369318, 3019807891, 3005700659, 2648729, 3038429246, 3006630150, 3010972758, 3005160949, 3006705815, 2182207, 3002618605, 2183744, 1928237, 2024311, 3010531069, 2649622, 3005210579, 2124215, 3015924373, 3013023969
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.