AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder

FDA Premarket Approval P120021 S023

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.

Pre-market Approval Supplement Details

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 p120021.

DeviceAmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2021-11-26
Decision Date2021-12-22
PMAP120021
SupplementS023
Product CodeMLV 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P120021Original Filing
S023 2021-11-26 Normal 180 Day Track No User Fee
S022
S021 2021-06-28 30-day Notice
S020
S019
S018 2020-05-06 30-day Notice
S017 2020-04-24 30-day Notice
S016
S015 2020-03-19 30-day Notice
S014 2020-03-17 30-day Notice
S013 2019-09-26 30-day Notice
S012 2019-06-24 Normal 180 Day Track No User Fee
S011 2019-02-27 30-day Notice
S010 2019-02-15 Normal 180 Day Track No User Fee
S009 2019-01-03 30-day Notice
S008
S007 2018-02-12 30-day Notice
S006 2018-01-30 Real-time Process
S005
S004 2017-07-06 30-day Notice
S003 2017-01-26 30-day Notice
S002 2016-11-23 Normal 180 Day Track No User Fee
S001 2016-11-17 Normal 180 Day Track No User Fee

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