Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device transcatheter septal occluder (atrial)
Definition For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
Product CodeOZG
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0

MDR Year MDR Reports MDR Events
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erosion 2 2
Cardiac Arrest 1 1
Chest Pain 1 1
Cardiac Tamponade 1 1
Pericardial Effusion 1 1
No Clinical Signs, Symptoms or Conditions 1 1

-
-