HVP_CRD 894 PIVSD HDE PAS

HVP CRD 894: The Amplatzer Post-Infarct VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study (CRD_894)

FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZERâ„¢ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZERâ„¢ PIVSD Occluder.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
N/A
NCT03165526
Heart and Vascular
Other
Robert Hodson MD
Abbott Vascular
Michelle Dixon
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • TOC Gateway - Heart Clinic