Atlas FDA

Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

FDA premarket approval P140009/S119 · decided 2025-06-24

Approval details

PMA number
P140009
Supplement
S119
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Applicant
ABBOTT MEDICAL
Date received
2025-06-03
Decision date
2025-06-24
Days to decision
21 days
Decision code
OK30
Product code
MHY
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
approval for the supplier of resistors contained within Abbott’s family of rechargeable Implantable Pulse Generator printed circuit board assemblies to qualify an additional production line, located at Vishay’s site in Huizhou, China, for an existing supplier for completing the backend processing of resistors

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