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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 NumberS004
Date Received11/14/2025
Decision Date12/18/2025
Product Code OZG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
consolidation of manufacturing operations for the Occlutech ASD Occluder by moving all remaining production activities and equipment from your 'TIP' (Technologie-und Innovationspark) facility to your 'BIZ' (Bioinstrumentezentrum) facility
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