Amplatzer Amulet Left Atrial Appendage Occluder

FDA Premarket Approval P200049 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

An update to the dome weld and end screw weld visual acceptance criteria

DeviceAmplatzer Amulet Left Atrial Appendage Occluder
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantAbbott Medical
Date Received2021-11-05
Decision Date2021-11-16
PMAP200049
SupplementS003
Product CodeNGV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P200049Original Filing
S003 2021-11-05 30-day Notice
S002
S001 2021-08-24 30-day Notice

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