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Liberta RC Deep Brain Stimulation Implantable Pulse Generator

FDA premarket approval P140009/S116 · decided 2025-06-09

Approval details

PMA number
P140009
Supplement
S116
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Liberta RC Deep Brain Stimulation Implantable Pulse Generator
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Applicant
ABBOTT MEDICAL
Date received
2025-03-11
Decision date
2025-06-09
Days to decision
90 days
Decision code
APPR
Product code
MHY
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
approval for 1) qualifying an alternate Gemini implanted pulse generator (IPG) feedthrough supplier, Integer, along with associated design change, in which the alumina in the ceramic portion of the feedthrough is increasing in level of purity; and 2) qualifying an optional Gemini IPG Can buffing step at current IPG Can supplier, National Manufacturing, to remove cosmetic defect marks on the IPG Can.

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