PMA P200049S010

Device: Amplatzer Amulet Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S010
Product code: NGV
Decision date: 2025-03-05
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: a change in air quality sampling test method and air microbe action and alert levels used in Abbott’s internal quality monitoring procedures

Current openFDA PMA Record#

Device: Amplatzer Amulet Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S010
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-03-05
Decision code: OK30
Date received: 2025-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in air quality sampling test method and air microbe action and alert levels used in Abbott’s internal quality monitoring procedures