FDA.reportPublic FDA data

WATCHMAN®

Primary DI
08714729838265
Brand
WATCHMAN®
Company
BOSTON SCIENTIFIC CORPORATION
Model
M635WU33060
Catalog number
M635WU33060
Device description
Left Atrial Appendage Closure Device with Delivery System
Published
2015-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
P130013009
P130013010
P130013025
P130013033
P130013035
P130013039
P130013041

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
P130013009WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013010WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013025WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013033WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013035WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013039WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013041WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729838265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729838265087147298382658714729838265

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderA sterile, disk-like, device used for the non-surgical closure of cardiac defects. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester). It is implanted using a dedicated catheter/sheath and delivery cable. The device is used to treat cardiac disorders that may include, but not limited to; an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

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

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506040147WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506040154WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506040161WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506040178WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506040185WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506040192WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004583WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004590WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004606WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004613WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004620WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00191506004637WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONNGV2023-09-12
00811806013459Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013466Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
00811806013473Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
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
08714729838197WATCHMAN® Access SystemBOSTON SCIENTIFIC CORPORATIONNGV2015-03-20