PMA P110021S027

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, CRIMPER ASCENDRA BALLOON CATHETER
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S027
Product code: NPT
Decision date: 2013-10-11
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, CRIMPER ASCENDRA BALLOON CATHETER
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S027
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-10-11
Decision code: OK30
Date received: 2013-09-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.