PMA P200049S014

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S014
Product code: NGV
Decision date: 2025-12-23
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: approval for minor dimensional changes to the hemostasis valve accessory device supplied with the Amulet LAAO as well as clarifications to your instructions for use including updates to the MRI labeling.

Current openFDA PMA Record#

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S014
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-12-23
Decision code: APPR
Date received: 2025-09-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for minor dimensional changes to the hemostasis valve accessory device supplied with the Amulet LAAO as well as clarifications to your instructions for use including updates to the MRI labeling.