FDA.reportPublic FDA data

NA

Primary DI
00643169887435
Brand
NA
Company
MEDTRONIC, INC.
Model
3550-03
Device description
ACCY KIT 3550-03 DBS TWSTLCK SCRNCBL FWU
Published
2017-10-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZWStimulator, electrical, implantable, for incontinence
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840001231
P960009287
P970004250

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840001231ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P960009287MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY
P970004250MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169887435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169887435006431698874356431698874350643169887435

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
00812537030272Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030296Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030883Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537036953Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-01-28
08714729989301NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2021-01-28
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21