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SJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System

FDA premarket approval P140009/S037 · decided 2018-07-19

Approval details

PMA number
P140009
Supplement
S037
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Applicant
ABBOTT MEDICAL
Date received
2018-02-13
Decision date
2018-07-19
Days to decision
156 days
Decision code
APPR
Product code
MHY
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
Approval for:1) P140009/S037: MR Conditional labeling, Firmware version 1.3, and Clinician Programmer and Patient Controller Apps version 3.7 (DBS MRI mode, DBS shared frequency mode, DBS Multistim Programming, DBS Monopolar Survey Mode, and minor software changes); and2) P010032/S141 and P150004/S20: Firmware version 1.3 and Clinician Programmer and Patient Controller Apps version 3.7 (minor software changes).

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