PMA P200049S009

Device: Amplatzer Amulet Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S009
Product code: NGV
Decision date: 2025-04-22
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Continued Follow-up of the Amulet IDE Cohort

Current openFDA PMA Record#

Device: Amplatzer Amulet Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S009
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-04-22
Decision code: APPR
Date received: 2024-12-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the Continued Follow-up of the Amulet IDE Cohort