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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOcclutech® ASD Occluder and Occlutech® Pistol Pusher
Generic NameTranscatheter septal occluder (atrial)
ApplicantOcclutech Holding AG
Feldstrasse 22
Schaffhausen 8200
PMA NumberP200032
Date Received07/07/2020
Decision Date12/29/2023
Product Code OZG 
Docket Number 24M-0759
Notice Date 02/21/2024
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type atrial septal defects (ASD). Patients indicated for ASD closure have:• Echocardiographic evidence of ostium secundum-type ASD, • Clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ? 1.5 or RV enlargement).The Occlutech Pistol Pusher is a percutaneous, transcatheter pusher system designed for the delivery of the Occlutech ASD Occluder to the implantation area. It is used via a minimally invasive catheter delivery system technique.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 
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