FDA.reportPublic FDA data

PMA P030054S374

Device
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
Applicant
ABBOTT MEDICAL
Product code
NIK
Decision date
2020-06-30
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.

Current openFDA PMA Record#

Device
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S374
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2020-06-30
Decision code
APPR
Date received
2019-11-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.