PMA P110021S008

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S008
Product code: NPT
Decision date: 2013-03-12
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.

Current openFDA PMA Record#

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S008
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-03-12
Decision code: APPR
Date received: 2013-02-12
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR ADDITIONAL VISUAL INSPECTION STEPS FOR AND REMOVAL, IF FOUND, OF FIBERS AND PARTICLES ON SUB-ASSEMBLED AND FINAL ASSEMBLED REPLACEMENT HEART VALVES PRIOR TO PACKAGING.