FDA.reportPublic FDA data

Exclaim™

Primary DI
05415067017758
Brand
Exclaim™
Company
ST. JUDE MEDICAL, INC.
Model
3225
Catalog number
3225
Device description
Lead, 90 cm
Published
2015-03-17
Public version status
Update
Distribution status
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063080000
P010032020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063080000TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADSAdvanced Neuromodulation Systems2006-12-12GZB
P010032020GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSABBOTT MEDICAL2001-11-21LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067017758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067017758054150670177585415067017758

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length90Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit
Special Storage Condition, Specify00DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Special Storage Condition, Specify00DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

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Primary DI, Brand, Company table
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08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
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08714729931492NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-05-03
08714729763352Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-02-23
08714729789697Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729789703Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729767534Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767541Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767558Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779957NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779964NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789567Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789581Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797807Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797814Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797821Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797838NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729821540NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767640Precision ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09
08714729772699NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09
08714729791973Clik™ AnchorBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-11-09