AMPLATZER MUSCULAR VSD OCCLUDER

Transcatheter Septal Occluder

FDA Premarket Approval P040040

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the amplatzer muscular vsd occluder. The device is indicated for use in patients with a complex ventricular septal defect (vsd) of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. High risk anatomical factors for transatrial or transarterial surgical closure include patients: 1) requiring left ventriculotomy or an extensive right ventriculotomy; 2) with a failed previous vsd closure; 3) with multiple apical and/or anterior muscular vsds (? Swiss cheese septum? ); or 4) with posterior apical vsds covered by trabeculae.

DeviceAMPLATZER MUSCULAR VSD OCCLUDER
Classification NameTranscatheter Septal Occluder
Generic NameTranscatheter Septal Occluder
ApplicantAbbott Medical
Date Received2004-09-30
Decision Date2007-09-07
Notice Date2007-11-19
PMAP040040
SupplementS
Product CodeMLV
Docket Number07M-0446
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P040040Original Filing
S045 2021-11-22 Real-time Process
S044 2021-06-28 30-day Notice
S043 2020-05-06 30-day Notice
S042 2020-04-24 30-day Notice
S041
S040 2020-03-19 30-day Notice
S039 2020-03-17 30-day Notice
S038 2019-09-26 30-day Notice
S037 2019-06-24 Normal 180 Day Track No User Fee
S036 2019-02-27 30-day Notice
S035 2019-02-15 Normal 180 Day Track No User Fee
S034 2019-01-03 30-day Notice
S033 2018-02-12 30-day Notice
S032
S031 2017-07-06 30-day Notice
S030 2017-01-26 30-day Notice
S029 2016-07-01 30-day Notice
S028 2016-04-06 30-day Notice
S027 2016-03-14 30-day Notice
S026 2016-01-19 Normal 180 Day Track No User Fee
S025 2015-10-30 Normal 180 Day Track No User Fee
S024 2015-08-21 Normal 180 Day Track No User Fee
S023 2013-02-19 135 Review Track For 30-day Notice
S022 2013-02-06 Normal 180 Day Track
S021 2012-05-14 30-day Notice
S020 2012-04-24 30-day Notice
S019 2011-09-20 30-day Notice
S018 2011-03-09 30-day Notice
S017
S016 2011-01-19 30-day Notice
S015 2010-11-15 30-day Notice
S014 2010-06-09 Normal 180 Day Track No User Fee
S013 2010-04-21 30-day Notice
S012 2010-03-11 30-day Notice
S011
S010
S009 2009-02-11 Real-time Process
S008 2008-12-23 30-day Notice
S007 2008-12-09 Special (immediate Track)
S006 2008-11-28 Normal 180 Day Track No User Fee
S005 2008-02-25 135 Review Track For 30-day Notice
S004 2008-02-04 30-day Notice
S003 2008-01-28 30-day Notice
S002 2007-12-14 30-day Notice
S001 2007-11-06 30-day Notice

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.