FDA.reportPublic FDA data

NA

Primary DI
10681490078013
Brand
NA
Company
MEDTRONIC, INC.
Model
3550-06
Device description
ACCESSORY 3550-06 TUNNELING TOOLS
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960009027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960009027MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10681490078013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068149007801310681490078013

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. 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#

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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
00763000520083N/AMEDTRONIC, INC.QRB2021-07-23
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