PMA P110021S041

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S041
Product code: NPT
Decision date: 2014-08-04
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: MODIFY THE SAMPLING PLAN FOR ROUTINE MONITORING OF THE EDWARDS BALLOON CATHETER, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, NOVAFLEX+ DELIVERY SYSTEM AND ASCENDRA+ DELIVERY SYSTEM.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S041
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-08-04
Decision code: OK30
Date received: 2014-07-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFY THE SAMPLING PLAN FOR ROUTINE MONITORING OF THE EDWARDS BALLOON CATHETER, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, NOVAFLEX+ DELIVERY SYSTEM AND ASCENDRA+ DELIVERY SYSTEM.