Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

FDA Premarket Approval P200015 S021

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.

Pre-market Approval Supplement Details

DeviceEdwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS021 Date Received05/25/2022 Decision Date06/23/2022 Product Code NPV  Advisory Committee Cardiovascular Clinical TrialsNCT05378386 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-05-25
Decision Date2022-06-23
PMAP200015
SupplementS021
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressEdwards Lifesciences, LLC
one Edwards Way
irvine, CA 92614 PMA NumberP200015 Supplement NumberS021 Date Received05/25/2022 Decision Date06/23/2022 Product Code NPV  Advisory Committee Cardiovascular Clinical TrialsNCT05378386
Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of The Revised Protocol For The Post-approval Study 2: Alterra New Enrollment Study.

Supplemental Filings

Supplement NumberDateSupplement Type
P200015Original Filing
S032 2022-11-14 30-day Notice
S031 2022-10-25 30-day Notice
S030 2022-10-04 30-day Notice
S029
S028
S027 2022-08-25 30-day Notice
S026
S025
S024
S023 2022-06-30 30-day Notice
S022 2022-06-06 30-day Notice
S021 2022-05-25 Normal 180 Day Track No User Fee
S020
S019 2022-04-04 30-day Notice
S018
S017 2022-01-14 30-day Notice
S016 2021-11-03 Normal 180 Day Track No User Fee
S015 2021-10-19 30-day Notice
S014 2021-09-30 30-day Notice
S013 2021-08-30 30-day Notice
S012 2021-08-25 30-day Notice
S011
S010 2021-06-07 Normal 180 Day Track No User Fee
S009 2021-03-19 Normal 180 Day Track No User Fee
S008 2021-02-22 30-day Notice
S007 2020-12-17 30-day Notice
S006 2020-12-03 30-day Notice
S005
S004 2020-09-08 30-day Notice
S003 2020-11-17 30-day Notice
S002 2020-11-02 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
00690103210866 P200015 011
00690103210873 P200015 011

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