FDA.reportPublic FDA data

PMA P030054S384

Device
Quickflex µ, Quartet
Applicant
ABBOTT MEDICAL
Product code
NIK
Decision date
2020-10-16
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Approval for the use of an optimized method for the calculation of the amount of DSP content identified on product labels for CRT and passive fixation cardiac leads.

Current openFDA PMA Record#

Device
Quickflex µ, Quartet
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S384
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2020-10-16
Decision code
APPR
Date received
2020-08-11
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the use of an optimized method for the calculation of the amount of DSP content identified on product labels for CRT and passive fixation cardiac leads.