FDA.reportPublic FDA data

N/A

Primary DI
00199150017850
Brand
N/A
Company
MEDTRONIC, INC.
Model
RS6230
Device description
RECHARGE SYSTEM RS6230 PERCEPT RC DBS US
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBXStimulator, thalamic, epilepsy, implanted
MHYStimulator, electrical, implanted, for parkinsonian tremor
MRUimplanted subcortical electrical Stimulator (motor disorders)
NHLStimulator, electrical, implanted, for parkinsonian symptoms
PJSStimulator, electrical, implanted, for essential tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBXStimulator, Thalamic, Epilepsy, ImplantedUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Unknownf
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020007329
P960009438

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007329
P960009438MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150017850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150017850001991500178501991500178500199150017850

GMDN Terms#

Term, Definition table
TermDefinition
Implant battery chargerAn electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device. Battery-powered device types may include a line-powered charger (e.g., docking station); devices intended to hold/stabilise the device during use (e.g., implant battery charger belt/collar) may be included with this device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199309002416N/AMEDTRONIC, INC.MBX2026-05-29
B1132L2HS000050Shoulder Innovations InSet Slap Hammer BaseShoulder Innovations, Inc.MBX2025-12-12
B1132L1S0400020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1000020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1000030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1200020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1200030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L2HB000020Shoulder Innovations InSet 135 Instrument Case/TrayShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB000030Shoulder Innovations InSet 185 Instrument Case/TrayShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235040Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235060Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235080Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235100Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235120Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB285060Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB285080Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB285100Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB285120Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HI135010Shoulder Innovations InSet 135 Impaction Stand TowerShoulder Innovations, Inc.MBX2025-12-12
B1132L2HI135020Shoulder Innovations InSet 135/185 Impaction Stand BaseShoulder Innovations, Inc.MBX2025-12-12
B1132L2HI135030Shoulder Innovations InSet 135/185 Adjustable FootShoulder Innovations, Inc.MBX2025-12-12
B1132L2HI185010Shoulder Innovations InSet 185 Impaction Stand TowerShoulder Innovations, Inc.MBX2025-12-12
B1132L2HR135040Shoulder Innovations InSet FxR 135 Combination ReamerShoulder Innovations, Inc.MBX2025-12-12