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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.
 
DeviceAmplatzer™ Talisman™ PFO Occluder
Generic NameTranscatheter septal occluder
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP120021
Supplement NumberS020
Date Received04/01/2021
Decision Date09/27/2021
Product Code MLV 
Advisory Committee Cardiovascular
Clinical TrialsNCT00465270
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Amplatzer Talisman PFO Occluder (Talisman PFO); a line extension of the current Amplatzer PFO Occluder (PFO) product family.
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