FDA.reportPublic FDA data

WATCHMAN FLX™ Pro

Primary DI
00191506004590
Brand
WATCHMAN FLX™ Pro
Company
BOSTON SCIENTIFIC CORPORATION
Model
M635WU60240
Catalog number
M635WU60240
Device description
Left Atrial Appendage Closure Device with Delivery System
Published
2023-09-12
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
P130013057
P130013060
P130013064
P130013065
P130013074
P130013075
P130013077
P130013081
P130013084

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130013057WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013060WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013064WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013065WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013074WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013075WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013077WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013081WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013084WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506004590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506004590001915060045901915060045900191506004590

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac defect occluderAn implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

Device Sizes#

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

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
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
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
08714729838265WATCHMAN®BOSTON SCIENTIFIC CORPORATIONNGV2015-03-20
08714729838197WATCHMAN® Access SystemBOSTON SCIENTIFIC CORPORATIONNGV2015-03-20