PMA P200049S012

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S012
Product code: NGV
Decision date: 2025-09-18
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for modifications to the Amplatzer™ Amulet™ Left Atrial Appendage Occluder Instructions for Use (IFU) and Patient Manual to remove a warning related to late pericardial effusions and to update your post implant medication regimen to include the use of oral anticoagulants.

Current openFDA PMA Record#

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S012
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-09-18
Decision code: APPR
Date received: 2025-06-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the Amplatzer™ Amulet™ Left Atrial Appendage Occluder Instructions for Use (IFU) and Patient Manual to remove a warning related to late pericardial effusions and to update your post implant medication regimen to include the use of oral anticoagulants.