Product code MBX

Device name: Stimulator, Thalamic, Epilepsy, Implanted
Medical specialty: Unknown
Device class: 3
Review panel: NE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P960009S438	Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System	Medtronic, Inc.	2024-01-08
P960009S449	Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™	Medtronic, Inc.	2023-03-10
P960009S437	Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™	Medtronic, Inc.	2022-09-07
P960009S219	MEDTRONIC DBS THERAPY FOR EPILEPSY	Medtronic, Inc.	2018-04-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00199309002416	N/A	MEDTRONIC, INC.	2026-05-29
B1132L2HB235100	Shoulder Innovations InSet FxR 135 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HR135120	Shoulder Innovations InSet FxR 135 Combination Reamer	Shoulder Innovations, Inc.	2025-12-12
B1132L2HR135100	Shoulder Innovations InSet FxR 135 Combination Reamer	Shoulder Innovations, Inc.	2025-12-12
B1132L2HR135080	Shoulder Innovations InSet FxR 135 Combination Reamer	Shoulder Innovations, Inc.	2025-12-12
B1132L2HR135060	Shoulder Innovations InSet FxR 135 Combination Reamer	Shoulder Innovations, Inc.	2025-12-12
B1132L2HR135040	Shoulder Innovations InSet FxR 135 Combination Reamer	Shoulder Innovations, Inc.	2025-12-12
B1132L2HI185010	Shoulder Innovations InSet 185 Impaction Stand Tower	Shoulder Innovations, Inc.	2025-12-12
B1132L2HI135030	Shoulder Innovations InSet 135/185 Adjustable Foot	Shoulder Innovations, Inc.	2025-12-12
B1132L2HI135020	Shoulder Innovations InSet 135/185 Impaction Stand Base	Shoulder Innovations, Inc.	2025-12-12
B1132L2HI135010	Shoulder Innovations InSet 135 Impaction Stand Tower	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB285120	Shoulder Innovations InSet FxR 185 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB285100	Shoulder Innovations InSet FxR 185 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB285080	Shoulder Innovations InSet FxR 185 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB285060	Shoulder Innovations InSet FxR 185 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB235120	Shoulder Innovations InSet FxR 135 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB235080	Shoulder Innovations InSet FxR 135 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB235060	Shoulder Innovations InSet FxR 135 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB235040	Shoulder Innovations InSet FxR 135 Humeral Stem Trial	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB000030	Shoulder Innovations InSet 185 Instrument Case/Tray	Shoulder Innovations, Inc.	2025-12-12
B1132L2HB000020	Shoulder Innovations InSet 135 Instrument Case/Tray	Shoulder Innovations, Inc.	2025-12-12
B1132L1S1200030	Shoulder Innovations InSet FxR 185	Shoulder Innovations, Inc.	2025-12-12
B1132L1S1200020	Shoulder Innovations InSet FxR 135	Shoulder Innovations, Inc.	2025-12-12
B1132L1S1000030	Shoulder Innovations InSet FxR 185	Shoulder Innovations, Inc.	2025-12-12
B1132L1S1000020	Shoulder Innovations InSet FxR 135	Shoulder Innovations, Inc.	2025-12-12
B1132L1S0800030	Shoulder Innovations InSet FxR 185	Shoulder Innovations, Inc.	2025-12-12
B1132L1S0800020	Shoulder Innovations InSet FxR 135	Shoulder Innovations, Inc.	2025-12-12
B1132L1S0600030	Shoulder Innovations InSet FxR 185	Shoulder Innovations, Inc.	2025-12-12
B1132L1S0600020	Shoulder Innovations InSet FxR 135	Shoulder Innovations, Inc.	2025-12-12
B1132L1S0400020	Shoulder Innovations InSet FxR 135	Shoulder Innovations, Inc.	2025-12-12

Product code MBX

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