FDA.reportPublic FDA data

NA

Primary DI
00613994752178
Brand
NA
Company
MEDTRONIC, INC.
Model
3625
Device description
ACC 3625 SCREENER BEI REDESIGN US MKT
Published
2014-09-23
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
EZWStimulator, electrical, implantable, for incontinence
GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MFRStimulator, brain, implanted, for behavior modification
MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
MRUimplanted subcortical electrical Stimulator (motor disorders)
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
OLMDeep brain stimulator for obsessive compulsive disorder (OCD)
PJSStimulator, electrical, implanted, for essential tremor
QONImplanted electrical device intended for treatment of fecal incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MFRStimulator, Brain, Implanted, For Behavior ModificationUnknownf
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Unknownf
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)Unknownf
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080025020
P840001178
P960009108
P970004104

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025020MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON
P840001178ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P960009108MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY
P970004104MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994752178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994752178006139947521786139947521780613994752178

GMDN Terms#

Term, Definition table
TermDefinition
Implantable incontinence-control electrical stimulation systemAn assembly of battery-powered devices intended to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It is typically implanted in the abdomen/pelvic region and consists of implantable electrodes and pulse generator with a receiver, and an external programmer/transmitter that communicates with the implanted receiver.

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
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
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00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
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

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