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 revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170038.
|Device||CentriMag Circulatory Support System|
|Generic Name||Ventricular (assist) Bypass|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol|
|Applicant Address||Abbott 6035 Stoneridge Drive pleasanton, CA 94588|
|Supplement Number||Date||Supplement Type|
|S007||2021-08-02||Normal 180 Day Track No User Fee|
|S005||2020-07-31||Normal 180 Day Track No User Fee|
|S001||2020-01-08||Normal 180 Day Track No User Fee|