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.
The addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica
|Device||Amplatzer Amulet Left Atrial Appendage Occluder|
|Generic Name||System, Appendage Closure, Left Atrial|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Abbott Medical 5050 Nathan Lane North plymouth, MN 55442|
|Supplement Number||Date||Supplement Type|