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 for a manufacturing site located at gerresheimer regensburg gmbh in pfreimd, germany for assembling and packaging the blood pump.
|Device||CentriMag Circulatory Support System|
|Generic Name||Ventricular (assist) Bypass|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Location Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Abbott 6035 Stoneridge Drive pleasanton, CA 94588|
|Supplement Number||Date||Supplement Type|
|S001||2020-01-08||Normal 180 Day Track No User Fee|