PMA P200049S007

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S007
Product code: NGV
Decision date: 2024-10-01
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: the addition of Centerpiece Tijuana Mexico as an alternative Ethylene Oxide (EO) sterilization facility for the sterilization of the provided devices in scope approved under the PMA/HDE numbers P000039, P02004, P200049, P120021, P040040, H070005, P190023

Current openFDA PMA Record#

Device: Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Applicant: ABBOTT MEDICAL
PMA number: P200049
Supplement: S007
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2024-10-01
Decision code: APPR
Date received: 2024-07-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of Centerpiece Tijuana Mexico as an alternative Ethylene Oxide (EO) sterilization facility for the sterilization of the provided devices in scope approved under the PMA/HDE numbers P000039, P02004, P200049, P120021, P040040, H070005, P190023