FDA.reportPublic FDA data

PMA P030054S379

Device
Quickflex µ, Quartet
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S379
Product code
NIK
Decision date
2020-06-18
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.

Current openFDA PMA Record#

Device
Quickflex µ, Quartet
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S379
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.