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.
Approval of the protocol for the post approval study "registry-based real world use surveillance of the portico tavi system. "
|Device||Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System|
|Generic Name||Aortic Valve, Prosthesis, Percutaneously Delivered|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol|
|Applicant Address||Abbott Medical 177 County Road B. East st. Paul, MN 55117|
|Supplement Number||Date||Supplement Type|
|S001||2021-10-15||Normal 180 Day Track No User Fee|