PMA P110021S046

Device: ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S046
Product code: NPT
Decision date: 2014-10-23
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: CHANGES TO THE SAMPLING PLAN FOR PRODUCT VERIFICATION TESTING OF THE DELIVERY SYSTEMS AND ACCESSORIES MANUFACTURED AT THE IRVINE, CALIFORNIA FACILITY.

Current openFDA PMA Record

Device: ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S046
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-10-23
Decision code: OK30
Date received: 2014-10-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE SAMPLING PLAN FOR PRODUCT VERIFICATION TESTING OF THE DELIVERY SYSTEMS AND ACCESSORIES MANUFACTURED AT THE IRVINE, CALIFORNIA FACILITY.