PMA P040021S061

Device: Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S061
Product code: LWR
Decision date: 2026-06-22
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for a next generation of the Epic family of tissue heart valves, collectively referred to as Epic Elite/G3. The changes to the Epic Elite/G3 valves include the addition of an expansion feature on the stent to facilitate future Valve-in-Valve (ViV) procedures, a change in stent material to an equivalent material from the same supplier, and minor marking and suture changes.

Current openFDA PMA Record#

Device: Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S061
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2026-06-22
Decision code: APPR
Date received: 2025-12-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a next generation of the Epic family of tissue heart valves, collectively referred to as Epic Elite/G3. The changes to the Epic Elite/G3 valves include the addition of an expansion feature on the stent to facilitate future Valve-in-Valve (ViV) procedures, a change in stent material to an equivalent material from the same supplier, and minor marking and suture changes.