DEVICE: WATCHMAN FLX™ (08714729860525)
Device Identifier (DI) Information
WATCHMAN FLX™
M635WU50350
In Commercial Distribution
M635WU50350
BOSTON SCIENTIFIC CORPORATION
M635WU50350
In Commercial Distribution
M635WU50350
BOSTON SCIENTIFIC CORPORATION
Left Atrial Appendage Closure Device with Delivery System
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45418 | Cardiac defect occluder |
An 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NGV | System, appendage closure, left atrial |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P130013 | 035 |
P130013 | 041 |
P130013 | 043 |
P130013 | 050 |
P130013 | 052 |
P130013 | 053 |
P130013 | 056 |
P130013 | 060 |
P130013 | 064 |
P130013 | 065 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 35 Millimeter |
Device Record Status
2a9be51b-cd0a-441f-b917-aa1958d30312
May 21, 2024
12
July 28, 2020
May 21, 2024
12
July 28, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined