Amplatzer Amulet Left Atrial Appendage Occluder

FDA Premarket Approval P200049 S001

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

The addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica

DeviceAmplatzer Amulet Left Atrial Appendage Occluder
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantAbbott Medical
Date Received2021-08-24
Decision Date2021-09-22
PMAP200049
SupplementS001
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
S001 2021-08-24 30-day Notice

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