PMA P190023S029

Device: Navitor™ TAVI System with Vision Technology
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S029
Product code: NPT
Decision date: 2026-06-03
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the Portico TAVI System prospective cohort study

Current openFDA PMA Record#

Device: Navitor™ TAVI System with Vision Technology
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S029
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-06-03
Decision code: APPR
Date received: 2025-12-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the Portico TAVI System prospective cohort study