PMA P130013S053

Device: WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
Applicant: Boston Scientific Corp
Product code: NGV
Decision date: 2023-01-20
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for changing the location of the wall thickness measurement on the WATCHMAN FLX implant and modifying the 20mm implant size wall thickness specification

Current openFDA PMA Record#

Device: WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S053
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2023-01-20
Decision code: APPR
Date received: 2022-09-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changing the location of the wall thickness measurement on the WATCHMAN FLX implant and modifying the 20mm implant size wall thickness specification