FDA.reportPublic FDA data

Senza

Primary DI
00813426020756
Brand
Senza
Company
NEVRO CORP.
Model
LEAD1058-90BP
Catalog number
LEAD1058-90BP
Device description
"Blue Lead Kit, 90cm with 5mm Spacing, Curved Stylet .016"" "
Published
2021-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

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
P130022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130022000NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEMNevro Corporation2015-05-08LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813426020756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813426020756008134260207568134260207560813426020756

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system leadA wire with a distal electrode, insulated with non-conductive material along its length, intended to be implanted in the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) to conduct electrical impulses for the relief/treatment of acute and/or chronic intractable pain. It is intended to conduct electrical impulses from a separate electrical stimulation system pulse generator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
926599155
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813426020671SenzaACCK4310ACCK43102021-03-24
00813426020626OmniaCHPS2500CHPS25002019-11-11
00813426020169Senza® PTTK1000PTTK10002015-05-21
00813426020879Nevro®MADP2008-25B2025-02-28
00813426020886Nevro®SADP2008-25B2025-02-28
00813426020091Nevro®SADP2008-25BSADP2008-25B2015-05-21
00813426020107Nevro® MADP2008-25BMADP2008-25B2015-05-21
00813426020565OmniaCHGR2500CHGR25002019-11-11
00813426020121Senza® CHGR1000CHGR10002015-05-21
00813426021227SenzaNIPG3000UNIPG3000U2025-11-07
00813426020787Nevro® ACCK8012-50PACCK8012-50P2022-04-11
00813426020794Nevro® ACCK8012-70PACCK8012-70P2022-04-11
00813426020800Nevro® ACCK8012-90PACCK8012-90P2022-04-11
00813426020725SenzaLEAD1058-50BPLEAD1058-50BP2021-04-30
00813426020763SenzaLEAD1058-70BPLEAD1058-70BP2021-04-29
00813426020824Nevro®LEAD2008-25B2025-02-28
00813426020831Nevro®LEAD2008-35B2025-02-28
00813426020848Nevro®LEAD2008-60B2025-02-28
00813426020077Nevro®LEAD2008-25BLEAD2008-25B2015-05-21
00813426021098SenzaTLEAD1058-50B2025-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
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