FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ 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 AMPLATZER™ PIVSD Occluder.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Effectiveness Endpoint 1: Technical Success
Timeframe: End of Implant Procedure
Effectiveness Endpoint 2: Acute Closure
Timeframe: Up to 7 days post-procedure
Effectiveness Endpoint 3: Chronic Closure
Timeframe: 6 months or later following a PIVSD device implant through study completion, an average of 1 year
Safety Endpoint 1: Acute Survival
Timeframe: Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure
Safety Endpoint 2: Chronic Survival
Timeframe: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure