PMA P190023S027

Device: Navitor Transcatheter Aortic Valve Implantation System
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S027
Product code: NPT
Decision date: 2025-09-22
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: the addition of a new second-tier supplier for the raw stainless steel material used in the manufacture of the Small FlexNav Delivery System, and a change in the pigment used to color the Small Navitor Loading System base extender

Current openFDA PMA Record#

Device: Navitor Transcatheter Aortic Valve Implantation System
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S027
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-09-22
Decision code: OK30
Date received: 2025-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new second-tier supplier for the raw stainless steel material used in the manufacture of the Small FlexNav Delivery System, and a change in the pigment used to color the Small Navitor Loading System base extender