- Device
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S035
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2020-07-21
- Decision code
- APPR
- Date received
- 2020-01-02
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System. The supplement requested approval for a modified version of the WATCHMAN Left Atrial Appendage Closure Device with Delivery System referred to as the WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and to expand the indications to include anticoagulation therapy. These devices are indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:1) Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;2) Are deemed by their physicians to be suitable for anticoagulation therapy; and3) 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.