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Trade Name | THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER |
Classification Name | transcatheter septal occluder |
Generic Name | transcatheter septal occluder |
Applicant |
Abbott Medical |
177 county road b east |
st. paul, MN 55117 |
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HDE Number | H070005 |
Date Received | 06/18/2007 |
Decision Date | 01/10/2017 |
Product Code | |
Docket Number | 17M-0180 |
Notice Date | 01/12/2017 |
Advisory Committee |
Cardiovascular |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the amplatzer post-infarct muscular vsd occluder. The amplatzer post-infarct muscular vsd occluder is a percutaneous transcatheter occlusion device intended for closure of post myocardial infarct muscular ventricular septal defects in patients who are not satisfactory surgical candidates. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 |