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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 and Occlutech® Pistol Pusher
Generic NameTranscatheter septal occluder (atrial)
ApplicantOcclutech Holding AG
Feldstrasse 22
Schaffhausen 8200
PMA NumberP200032
Supplement NumberS002
Date Received03/21/2025
Decision Date04/18/2025
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  
to add a new manufacturing location, ‘BIZ’ (Bioinstrumentezentrum), within the same currently-approved establishment (under same FEI) for the manufacture of the Occlutech ASD Occluder
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