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PMA P200049S015

Device
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant
ABBOTT MEDICAL
PMA number
P200049
Supplement
S015
Product code
NGV
Decision date
2026-02-12
Classification
Cardiovascular
Generic name
System, appendage closure, left atrial
Approval order statement
to add an alternate laser welder to use in the manufacturing of the Amplatzer™ Amulet™ and Piccolo™ Occluders and to extend an existing laser cutter used for the Amulet™ to the Piccolo™ manufacturing process

Current openFDA PMA Record#

Device
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant
ABBOTT MEDICAL
PMA number
P200049
Supplement
S015
Product code
NGV
Generic name
System, appendage closure, left atrial
Decision date
2026-02-12
Decision code
OK30
Date received
2026-01-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to add an alternate laser welder to use in the manufacturing of the Amplatzer™ Amulet™ and Piccolo™ Occluders and to extend an existing laser cutter used for the Amulet™ to the Piccolo™ manufacturing process