FDA.reportPublic FDA data

NA

Primary DI
05415067045713
Brand
NA
Company
ADVANCED NEUROMODULATION SYSTEMS, INC.
Model
12710
Catalog number
12710
Device description
Port Plug
Published
2023-01-04
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
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

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
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010032186
P140009087

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010032186GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSABBOTT MEDICAL2001-11-21LGW
P140009087BRIO NEUROSTIMULATION SYSTEMABBOTT MEDICAL2015-06-12MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067045710PackageGS12In Commercial Distribution
05415067045713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506704571015415067045710
05415067045713054150670457135415067045713

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pulse generator port plugA non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73°F)
Storage Environment Temperature23 Degrees Celsius0
Storage Environment Temperature73 Degrees Fahrenheit0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
021675699
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054111N/A121012102026-03-02
05415067055880Proclaim™788478842026-02-13
05415067055842Proclaim™388438842026-02-13
05415067055866Infinity™688468842026-02-13
05415067053060NAMN13650MN136502025-12-07
05415067051899NA66700667002025-01-24
05415067051905NA36700367002025-01-24
05415067047670NA66000660002024-02-16
05415067045652NA16750167502023-01-04
05415067045676NA16760167602023-01-04
05414734400107NA111211122014-11-12
05414734400176NA112011202014-10-23
05415067023971Proclaim™388438842016-03-31
05415067051882NA304230422025-04-09
05415067050311NeuroSphere™387638762025-01-17
05414734401500NA300930092015-04-25
05414734400961MTS™127312732014-10-22
05414734401548Quattrode™306630662015-04-25
05415067027313Proclaim™788478842017-03-23
05415067029072NA788578852017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966401NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966401NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729989240Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729989240Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729985037Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25
08714729985037Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-06-25
08714729985051Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-06-25
08714729985051Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25