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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES
Classification Nameaortic valve, prosthesis, percutaneously delivered
Generic Namereplacement heart valve
ApplicantEDWARDS LIFESCIENCES LLC.
PMA NumberP110021
Supplement NumberS004
Date Received12/04/2012
Decision Date07/02/2013
Product Code
NPT[ Registered Establishments with NPT ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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 indicated for 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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