Edwards Commander Delivery System

FDA Premarket Approval P200015 S030

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 Commander Delivery System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantEdwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS030 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-04
Decision Date2022-10-24
PMAP200015
SupplementS030
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressEdwards Lifesciences, LLC
one Edwards Way
irvine, CA 92614 PMA NumberP200015 Supplement NumberS030 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of Commander Delivery System Flex Shaft Subassembly Manufacturing At The Edwards Draper, UT Facility

Supplemental Filings

Supplement NumberDateSupplement Type
P200015Original Filing
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.