Watchman Left Atrial Appendage (Laa) Closure Technology

FDA premarket approval P130013 · System, appendage closure, left atrial

PMA numberP130013

Approval

Applicant
Boston Scientific Corp
Received
May 14, 2013
Decision date
March 13, 2015 (APPR)
Supplements
84, latest August 28, 2026
Product code
NGV – System, Appendage Closure, Left Atrial

Official FDA PMA record

Approval order statement

APPROVAL FOR THE WATCHMAN LAA CLOSURE TECHNOLOGY. THIS DEVICE IS INDICATED TO REDUCE THE RISK OF THROMBOEMBOLISM FROM THE LEFT ATRIAL APPENDAGE (LAA) IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION WHO: ARE AT INCREASED RISK FOR STROKE AND SYSTEMIC EMBOLISM BASED ON CHADS2 OR CHA2DS2-VASC SCORES AND ARE RECOMMENDED FOR ANTICOAGULATION THERAPY; ARE DEEMED BY THEIR PHYSICIANS TO BE SUITABLE FOR WARFARIN; AND HAVE AN APPROPRIATE RATIONALE TO SEEK A NON-PHARMACOLOGIC ALTERNATIVE TO WARFARIN, TAKING INTO ACCOUNT THE SAFETY AND EFFECTIVENESS OF THE DEVICE COMPARED TO WARFARIN.