FDA.reportPublic FDA data

Activa® RC

Primary DI
00763000924638
Brand
Activa® RC
Company
MEDTRONIC, INC.
Model
37612
Device description
INS 37612 ACTIVA RC DBS EMANUAL EN US
Published
2024-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLStimulator, electrical, implanted, for parkinsonian symptoms
PJSStimulator, electrical, implanted, for essential tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960009408

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960009408MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000924638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000924638007630009246387630009246380763000924638

GMDN Terms#

Term, Definition table
TermDefinition
Deep brain electrical stimulation systemAn assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199150017850N/AMEDTRONIC, INC.NHL2026-02-05
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00199150006045N/AMEDTRONIC, INC.NHL2026-02-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15