PMA P100041S044

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S044
Product code: NPT
Decision date: 2014-06-11
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL TO AUTOMATE LABEL PRINTING, IMPLEMENT NEW PEEL STRENGTH EQUIPMENT, AND RELOCATE MANUFACTURING RADIO-FREQUENCY IDENTIFICATION TAGS.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S044
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-06-11
Decision code: APPR
Date received: 2013-10-24
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO AUTOMATE LABEL PRINTING, IMPLEMENT NEW PEEL STRENGTH EQUIPMENT, AND RELOCATE MANUFACTURING RADIO-FREQUENCY IDENTIFICATION TAGS.