Atlas FDA

Brio Neurostimulation System

FDA premarket approval P140009/S093 · decided 2024-10-08

Approval details

PMA number
P140009
Supplement
S093
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Brio Neurostimulation System
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Applicant
ABBOTT MEDICAL
Date received
2024-02-22
Decision date
2024-10-08
Days to decision
229 days
Decision code
APPR
Product code
MHY
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
Approval for the addition of an alternate ethylene oxide (EO) sterilization site, Centerpiece Sterilization Corporation Cycle ABB-059-R, located in Tijuana, Mexico, for the following products:1) Abbott Medical Spinal Cord Stimulation (SCS) Systems: • Family of Proclaim, Proclaim XR & Proclaim Plus IPGs; Protégé MRI™ & Protégé IPGs; Prodigy MRI™ & Prodigy IPGs; Eon Mini™ IPG; Eterna SCS IPG• Associated SCS leads, extensions and accessories 2) Abbott Medical Deep Brain Stimulation Systems• Family

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