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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 Pistol Pusher
Generic NameTranscatheter septal occluder (atrial)
ApplicantOcclutech Holding AG
Feldstrasse 22
Schaffhausen 8200
PMA NumberP200032
Supplement NumberS005
Date Received03/04/2026
Decision Date05/11/2026
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 a revised Instructions for Use (IFU) for the Occlutech Pistol Pusher (OPP). The updated IFU introduces generalized handling instructions to standardize procedures across Occlutech devices
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