PMA P130013S077

Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S077
Product code: NGV
Decision date: 2025-09-04
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for an update to the push force specification applied to the manufacturing of the WATCHMAN FLX™ Pro Left Atrial Appendage (LAA) Closure Device with Delivery System

Current openFDA PMA Record#

Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S077
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-09-04
Decision code: APPR
Date received: 2025-06-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for an update to the push force specification applied to the manufacturing of the WATCHMAN FLX™ Pro Left Atrial Appendage (LAA) Closure Device with Delivery System