FDA.reportPublic FDA data

WATCHMAN FLX™

Primary DI
08714729860518
Brand
WATCHMAN FLX™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M635WU50310
Catalog number
M635WU50310
Device description
Left Atrial Appendage Closure Device with Delivery System
Published
2020-07-28
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
P130013035
P130013041
P130013043
P130013050
P130013052
P130013053
P130013056
P130013060
P130013064
P130013065
P130013074
P130013075
P130013081
P130013084

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130013035WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013041WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013043WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013050WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013052WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013053WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGYBoston Scientific Corp2015-03-13NGV
P130013056WATCHMAN 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
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
08714729860518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729860518087147298605188714729860518

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
Outer Diameter31Millimeter

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
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

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
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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
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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
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