PMA P100041S008

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S008
Product code: NPT
Decision date: 2012-08-20
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S008
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2012-08-20
Decision code: APPR
Date received: 2012-03-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO ADD THE EDWARDS TRANSCATHETER BALLOON CATHETERS, MODELS 9350BC20 AND 9350BC23 WITH A WORKING BALLOON LENGTH OF 4 CM, AND TO ADD SOME NEW CONTROL ENVIRONMENTS AT THE DRAPER FACILITY IN DRAPER, UTAH TO ACCOMMODATE THE MANUFACTURE OF THESE CATHETERS AT THAT FACILITY.