PMA P120021S025

Device: Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder
Applicant: ABBOTT MEDICAL
PMA number: P120021
Supplement: S025
Product code: MLV
Decision date: 2024-10-01
Classification: Cardiovascular
Generic name: Transcatheter septal occluder
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™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder
Applicant: ABBOTT MEDICAL
PMA number: P120021
Supplement: S025
Product code: MLV
Generic name: Transcatheter septal occluder
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