Amplatzer PFO Occluder

FDA Premarket Approval P120021 S015

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

Addition of an alternative bacterial endotoxin testing method.

DeviceAmplatzer PFO Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2020-03-19
Decision Date2020-04-16
PMAP120021
SupplementS015
Product CodeMLV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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