WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY

FDA premarket approval P130013 · decided 2015-03-13

Approval details

PMA number

P130013

Trade name

WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY

Generic name

System, appendage closure, left atrial

Applicant

Boston Scientific Corp

Date received

2013-05-14

Decision date

2015-03-13

Days to decision

668 days

Decision code

APPR

Product code

NGV

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Maple Grove, MN

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, TAKIN

510(k) clearances by this applicant