PMA P130013S075

Device: WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S075
Product code: NGV
Decision date: 2025-05-05
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for adding an alternative braiding method, including a component-level manufacturing process, design specification changes, and new visual standards used in inspection processes, for the manufacture of the insourced Delivery Sheath component of the WATCHMAN FLX ™ and WATCHMAN FLX Pro ™ Left Atrial Appendage (LAA) Closure Devices with Delivery Systems.

Current openFDA PMA Record#

Device: WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S075
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-05-05
Decision code: APPR
Date received: 2025-02-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for adding an alternative braiding method, including a component-level manufacturing process, design specification changes, and new visual standards used in inspection processes, for the manufacture of the insourced Delivery Sheath component of the WATCHMAN FLX ™ and WATCHMAN FLX Pro ™ Left Atrial Appendage (LAA) Closure Devices with Delivery Systems.