FDA.reportPublic FDA data

PMA P200049S021

Device
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant
ABBOTT MEDICAL
PMA number
P200049
Supplement
S021
Product code
NGV
Decision date
2026-08-28
Classification
Cardiovascular
Generic name
System, appendage closure, left atrial
Approval order statement
approval for updating the Amplatzer Amulet Left Atrial Appendage Occluder Instructions for Use to modify a contraindication and update the instructions to include an assessment of the relationship between the occluder landing zone and pulmonary artery to reduce the risk of pulmonary artery injury.

Current openFDA PMA Record#

Device
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant
ABBOTT MEDICAL
PMA number
P200049
Supplement
S021
Product code
NGV
Generic name
System, appendage closure, left atrial
Decision date
2026-08-28
Decision code
APPR
Date received
2026-08-10
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
approval for updating the Amplatzer Amulet Left Atrial Appendage Occluder Instructions for Use to modify a contraindication and update the instructions to include an assessment of the relationship between the occluder landing zone and pulmonary artery to reduce the risk of pulmonary artery injury.