- Device
- WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S074
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2025-07-16
- Decision code
- APPR
- Date received
- 2025-01-17
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanding the indications to include patients following catheter ablation for non-valvular atrial fibrillation and to add a new post-implant drug regimen to the device labeling. The WATCHMAN FLX™ Device and the WATCHMAN FLX™ Pro Device are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:•Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy;•Are deemed by their physicians to be suitable for anticoagulation therapy; and•Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.Following catheter ablation for non-valvular atrial fibrillation (concomitantly or sequentially with WATCHMAN FLX™ or WATCHMAN FLX™ Pro implantation): The WATCHMAN FLX™ and WATCHMAN FLX™ Pro devices are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:•Are at increased risk for stroke and systemic embolism based on CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy;•Are deemed by their physicians to be suitable for anticoagulation therapy.