PMA P910023

Device
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S448
Product code
LWS
Decision date
2026-07-21
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.

Current openFDA PMA Record#

Device
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S482
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2026-07-21
Decision code
APPR
Date received
2025-12-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.