Watchman and Watchman FLX Left Atrial Appendage Closure Device with Delivery System
by Boston Scientific PMA
Active
PMA P130013
Overview
The Watchman and Watchman FLX Left Atrial Appendage Closure Device with Delivery System is a Class III medical device classified as a system for appendage closure of the left atrium. It is designed to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who are at increased stroke risk and deemed suitable for anticoagulation therapy but seek a non-pharmacologic alternative to warfarin.
This device is delivered percutaneously via a catheter-based approach under fluoroscopic and transesophageal echocardiographic guidance. It is intended for single-use and is supplied sterile, requiring no further preparation before deployment. The Watchman and Watchman FLX systems are authorized under an FDA Premarket Approval (PMA) with PMA number P130013, adhering to strict regulatory standards for cardiovascular devices. Multiple registration numbers and FEI numbers correspond to variations of the device, ensuring traceability and compliance with regulatory requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP130013 | Date13 Mar 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-2765-2015
- Terminated Z-2766-2015
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.
Specification
- Trade Name
- Watchman Left Atrial Appendage (Laa) Closure Technology
- Generic Name
- System, appendage closure, left atrial
- FDA applicant
- Boston Scientific Corp
- PMA Number
- FDA Product Code
- NGV
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Other devices from Boston Scientific
Questions
What is the primary clinical purpose of the Watchman and Watchman FLX devices, and who are they intended for?
The Watchman and Watchman FLX devices are designed to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who are at increased stroke risk (based on CHADS2 or CHA2DS2-VASC scores). They are intended for patients who are recommended for anticoagulation therapy but prefer a non-pharmacologic alternative to warfarin, provided their physicians deem them suitable for warfarin and the device’s safety and effectiveness are considered.
How are the Watchman and Watchman FLX devices deployed, and what guidance is required during the procedure?
The devices are delivered percutaneously via a catheter-based approach under fluoroscopic (X-ray) and transesophageal echocardiographic (TEE) guidance. This ensures precise placement within the left atrial appendage to effectively close it and reduce thromboembolic risk.
Are the Watchman and Watchman FLX devices single-use or reusable, and do they require any preparation before use?
The devices are intended for single-use and are supplied sterile, requiring no further preparation before deployment. This ensures sterility and compliance with medical device standards for patient safety.
What regulatory pathway was followed for the approval of the Watchman and Watchman FLX devices, and what is the PMA number?
The devices were authorized under an FDA Premarket Approval (PMA) process, which is the regulatory pathway for high-risk Class III medical devices. The PMA number for this authorization is **P130013**, reflecting compliance with strict cardiovascular device standards.