PMA P010031S688

Device
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Bravia CRT-D, Bravia Quad CRT-D, Bravia Quad CRT-D, Claria MRI CRT-D, Claria MR
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA number
P010031
Supplement
S688
Product code
NIK 
Decision date
2020-01-16
Generic name
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Approval order statement
To Modify The Destructive Analysis Inspection Monitoring Frequency For Certain Header Welds In CRT-D, ICD, And IPG Families