FDA.reportPublic FDA data

DBS™

Primary DI
00763000274412
Brand
DBS™
Company
MEDTRONIC, INC.
Model
3391S-40
Device description
LEAD KIT 3391S-40 DBS STMLC RECLAIM EMAN
Published
2021-12-16
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
OLMDeep brain stimulator for obsessive compulsive disorder (OCD)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)Unknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H050003214
H050003226
H050003228

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H050003214
H050003226
H050003228

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000274412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000274412007630002744127630002744120763000274412

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-34 Degrees Celsius57 Degrees Celsius
Storage Environment Temperature-30 Degrees Fahrenheit135 Degrees Fahrenheit

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.OLM2026-08-07
00199309002416N/AMEDTRONIC, INC.OLM2026-05-29
00199150006045N/AMEDTRONIC, INC.OLM2026-02-02
00763000994198N/AMEDTRONIC, INC.OLM2025-10-19
00763000975029N/AMEDTRONIC, INC.OLM2025-03-07
00763000963040N/AMEDTRONIC, INC.OLM2025-02-17
00763000963057N/AMEDTRONIC, INC.OLM2025-02-17
00643169955653N'VISION®MEDTRONIC, INC.OLM2024-10-04
00763000924621Activa® SCMEDTRONIC, INC.OLM2024-05-30
00763000924614Activa® SCMEDTRONIC, INC.OLM2024-05-27
00763000916268Percept™ PC BrainSense™MEDTRONIC, INC.OLM2024-04-21
00763000662028N/AMEDTRONIC, INC.OLM2024-03-03
00763000640033N/AMEDTRONIC, INC.OLM2024-01-22
00763000523312N/AMEDTRONIC, INC.OLM2024-01-19
00763000523329N/AMEDTRONIC, INC.OLM2024-01-19
00763000875725NAMEDTRONIC, INC.OLM2023-12-09
00763000875718NAMEDTRONIC, INC.OLM2023-11-16
00763000875862N'VISION™MEDTRONIC, INC.OLM2023-11-16
00763000642174Percept™ PC BrainSense™MEDTRONIC, INC.OLM2023-01-15
00763000404413N/AMEDTRONIC, INC.OLM2022-05-02
00763000519216Percept™ PC BrainSense™MEDTRONIC, INC.OLM2021-10-17
00763000519223Activa® SCMEDTRONIC, INC.OLM2021-10-17
00763000519230Activa® SCMEDTRONIC, INC.OLM2021-10-17
00763000411916N/AMEDTRONIC, INC.OLM2021-07-30
00763000424107N/AMEDTRONIC, INC.OLM2021-04-18
00763000424114N/AMEDTRONIC, INC.OLM2021-04-18
00763000420994N/AMEDTRONIC, INC.OLM2020-12-21
00763000384326Activa® PCMEDTRONIC, INC.OLM2020-11-22
00763000384333Activa® SCMEDTRONIC, INC.OLM2020-11-22
00763000384340Activa® SCMEDTRONIC, INC.OLM2020-11-22