FDA.reportPublic FDA data

WATCHMAN® Access System

Primary DI
08714729838197
Brand
WATCHMAN® Access System
Company
BOSTON SCIENTIFIC CORPORATION
Model
M635TU10060
Catalog number
M635TU10060
Device description
Access Sheath with Dilator
Published
2015-03-20
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

Product Codes#

Code, Name table
CodeName
NGVSystem, appendage closure, left atrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGVSystem, Appendage Closure, Left AtrialUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130013000
P130013005
P130013008
P130013017
P130013019
P130013025

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130013000WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013005WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013008WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013017WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013019WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013025WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729838197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729838197087147298381978714729838197

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluder delivery kitA collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occlude; the cardiac occluder is not included. The devices are used in the treatment of cardiac disorders that may include (but not limited to) atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00191506004583WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
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00191506004606WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004613WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004620WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
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00811806013480Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013497Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013503Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013510Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013527Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
08714729860488WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
08714729860495WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
08714729860501WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
08714729860518WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
08714729860525WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
08714729838227WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20
08714729838234WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20
08714729838241WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20
08714729838258WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20
08714729838265WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20