PMA P130013S081

Device: WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S081
Product code: NGV
Decision date: 2025-11-06
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for additional warnings and instructions in to the WATCHMAN FLX and WATCHMAN FLX Pro System's Instructions for Use (IFU) to reduce the risk of air embolism during use.

Current openFDA PMA Record#

Device: WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S081
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-11-06
Decision code: APPR
Date received: 2025-10-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for additional warnings and instructions in to the WATCHMAN FLX and WATCHMAN FLX Pro System's Instructions for Use (IFU) to reduce the risk of air embolism during use.