Amplatzer PFO Occluder

FDA Premarket Approval P120021 S018

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

Implementation of parametric release as part of the sterilization process at the midwestern sterilization corporation facility

DeviceAmplatzer PFO Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2020-05-06
Decision Date2020-06-04
PMAP120021
SupplementS018
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
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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