FDA.reportPublic FDA data

N/A

Primary DI
00763000400873
Brand
N/A
Company
MEDTRONIC, INC.
Model
3330L
Device description
LIT 3330L DYSTONIA EMANUALS EN
Published
2020-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
H020007257

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007257

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000400873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000400873007630004008737630004008730763000400873

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

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