PMA P100041S019

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S019
Product code: NPT
Decision date: 2013-06-11
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S019
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-06-11
Decision code: APPR
Date received: 2012-12-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.