PMA P980016S727

Device
Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA number
P980016
Supplement
S727
Product code
LWS 
Decision date
2020-01-16
Generic name
Implantable Cardioverter Defibrillator (non-crt)
Approval order statement
To Modify The Destructive Analysis Inspection Monitoring Frequency For Certain Header Welds In CRT-D, ICD, And IPG Families