PMA P190023S028

Device: FlexNav Delivery System; Navitor Transcatheter Aortic Valves
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S028
Product code: NPT
Decision date: 2025-10-15
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins

Current openFDA PMA Record#

Device: FlexNav Delivery System; Navitor Transcatheter Aortic Valves
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S028
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-10-15
Decision code: OK30
Date received: 2025-09-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins