FDA.reportPublic FDA data

Penditure™

Primary DI
00763000791445
Brand
Penditure™
Company
MEDTRONIC, INC.
Model
LAAC35
Device description
CLIP PENDITURE LAAC35
Published
2023-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZXLeft atrial appendage clip, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZXLeft Atrial Appendage Clip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232295000LAA Exclusion SystemSyntheon, LLC2023-08-30PZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000791445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000791445007630007914457630007914450763000791445

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913525AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913532AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913549AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913556AtriClip PROV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914270AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914287AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914294AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143914300AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-28
10840143913327AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913334AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913341AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913358AtriClip® Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-20
10840143913402AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913419AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913426AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143913433AtriClip® FlexV® LAA Exclusion SystemATRICURE, INC.PZX2026-04-13
10840143919602AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143919619AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143919626AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143919633AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-04-10
10840143913365AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-03-25
10840143913372AtriClip® FLEX™ Gillinov-Cosgrove™ LAA Exclusion SystemATRICURE, INC.PZX2026-03-25