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Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

FDA premarket approval P030054/S398 · decided 2022-05-17

Approval details

PMA number
P030054
Supplement
S398
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
ABBOTT MEDICAL
Date received
2022-03-07
Decision date
2022-05-17
Days to decision
71 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software andMerlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.

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