PMA P140031S194

Device: SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S194
Product code: NPT
Decision date: 2025-10-10
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval of the revised protocol for the "Continued Follow-up of 'EARLY TAVR' Premarket Cohort" postapproval study ordered under P140031/S182.

Current openFDA PMA Record#

Device: SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S194
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-10-10
Decision code: APPR
Date received: 2025-09-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the "Continued Follow-up of 'EARLY TAVR' Premarket Cohort" postapproval study ordered under P140031/S182.