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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOcclutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
Generic NameTranscatheter septal occluder (atrial)
ApplicantOcclutech Holding AG
Feldstrasse 22
Schaffhausen 8200
PMA NumberP200032
Supplement NumberS001
Date Received03/08/2024
Decision Date06/07/2024
Product Code OZG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extending the shelf-life for both the Occlutech ASD Occluder (ASD) and the Occlutech Pistol Pusher (OPP) to 5 years
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