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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantEDWARDS LIFESCIENCES LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP110021
Supplement NumberS004
Date Received12/04/2012
Decision Date07/02/2013
Withdrawal Date 03/18/2019
Product Code NPT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN MODIFICATIONS TO THE ASCENDRA BALLOON CATHETER, MODELS 9100BCL23 (23MM) AND 9100BCL26 (26MM), AND THE ASCENDRA INTRODUCER SHEATH SET, MODEL 91001S. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ASCENDRA 3 DELIVERY SYSTEM, MODELS 9120AS23 (23MM) AND 9120AS26 (26MM) AND ASCENDRA 3 INTRODUCER SHEATH SET, MODEL 9120IS (26F) AND IS INDICATEDFOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (DELIVERY SYSTEM) AND FOR THE INTRODUCTION AND REMOVAL OF DEVICES USED WITH THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (INTRODUCER SHEATH SET).
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