FDA.reportPublic FDA data

WATCHMAN FLX™ Pro

Primary DI
00191506004637
Brand
WATCHMAN FLX™ Pro
Company
BOSTON SCIENTIFIC CORPORATION
Model
M635WU60400
Catalog number
M635WU60400
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
00191506004637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506004637001915060046371915060046370191506004637

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
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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
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00811806013527Amplatzer™ Amulet™ST. JUDE MEDICAL, INC.NGV2021-08-16
08714729860488WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
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08714729860501WATCHMAN FLX™BOSTON SCIENTIFIC CORPORATIONNGV2020-07-28
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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