FDA.reportPublic FDA data

MEDTRONIC® DBS™

Primary DI
00643169141742
Brand
MEDTRONIC® DBS™
Company
MEDTRONIC, INC.
Model
3319
Device description
LIT 3319L DYSTONIA 37601 W/3389S NEW EXT
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRUimplanted subcortical electrical Stimulator (motor disorders)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020007088

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007088

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169141742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169141742006431691417426431691417420643169141742

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
796986144
Device count
1
Lot or batch
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
00199150017850N/AMEDTRONIC, INC.MRU2026-02-05
00199150006045N/AMEDTRONIC, INC.MRU2026-02-02
00763000994198N/AMEDTRONIC, INC.MRU2025-10-19
00763000292102N/AMEDTRONIC, INC.MRU2025-09-05
00763000975029N/AMEDTRONIC, INC.MRU2025-03-07
00763000963040N/AMEDTRONIC, INC.MRU2025-02-17
00763000963057N/AMEDTRONIC, INC.MRU2025-02-17
00643169955653N'VISION®MEDTRONIC, INC.MRU2024-10-04
00763000924621Activa® SCMEDTRONIC, INC.MRU2024-05-30
00763000924614Activa® SCMEDTRONIC, INC.MRU2024-05-27
00763000810535N/AMEDTRONIC, INC.MRU2024-04-22
00763000810542N/AMEDTRONIC, INC.MRU2024-04-22
00763000810559N/AMEDTRONIC, INC.MRU2024-04-22
00763000810566N/AMEDTRONIC, INC.MRU2024-04-22
00763000810573N/AMEDTRONIC, INC.MRU2024-04-22
00763000810580N/AMEDTRONIC, INC.MRU2024-04-22
00763000916268Percept™ PC BrainSense™MEDTRONIC, INC.MRU2024-04-21
00763000662028N/AMEDTRONIC, INC.MRU2024-03-03
00763000564353N/AMEDTRONIC, INC.MRU2024-01-22
00763000564346Percept™ RCMEDTRONIC, INC.MRU2024-01-21
00763000523312N/AMEDTRONIC, INC.MRU2024-01-19
00763000523329N/AMEDTRONIC, INC.MRU2024-01-19
00763000612832N/AMEDTRONIC, INC.MRU2024-01-19
00763000875725NAMEDTRONIC, INC.MRU2023-12-09
00763000875718NAMEDTRONIC, INC.MRU2023-11-16
00763000875862N'VISION™MEDTRONIC, INC.MRU2023-11-16
00763000642174Percept™ PC BrainSense™MEDTRONIC, INC.MRU2023-01-15
00763000404413N/AMEDTRONIC, INC.MRU2022-05-02
00763000274320DBS™MEDTRONIC, INC.MRU2021-12-16
00763000274399DBS™MEDTRONIC, INC.MRU2021-12-16