WATCHMAN FLX™ M635WU50350

GUDID 08714729860525

Left Atrial Appendage Closure Device with Delivery System

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder
Primary Device ID08714729860525
NIH Device Record Key2a9be51b-cd0a-441f-b917-aa1958d30312
Commercial Distribution StatusIn Commercial Distribution
Brand NameWATCHMAN FLX™
Version Model NumberM635WU50350
Catalog NumberM635WU50350
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter35 Millimeter
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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729860525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGVSystem, appendage closure, left atrial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-05
Device Publish Date2020-07-28

On-Brand Devices [WATCHMAN FLX™]

08714729860525Left Atrial Appendage Closure Device with Delivery System
08714729860518Left Atrial Appendage Closure Device with Delivery System
08714729860501Left Atrial Appendage Closure Device with Delivery System
08714729860495Left Atrial Appendage Closure Device with Delivery System
08714729860488Left Atrial Appendage Closure Device with Delivery System

Trademark Results [WATCHMAN FLX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATCHMAN FLX
WATCHMAN FLX
97459003 not registered Live/Pending
Boston Scientific Scimed, Inc.
2022-06-15
WATCHMAN FLX
WATCHMAN FLX
88228883 not registered Live/Pending
Boston Scientific Scimed, Inc.
2018-12-13
WATCHMAN FLX
WATCHMAN FLX
87486602 not registered Dead/Abandoned
Atritech, Inc.
2017-06-13
WATCHMAN FLX
WATCHMAN FLX
86154069 not registered Dead/Abandoned
Atritech, Inc.
2013-12-30

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