Atlas FDA

Edwards Commander Delivery System

FDA premarket approval P200015/S026 · decided 2023-03-09

Approval details

PMA number
P200015
Supplement
S026
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Edwards Commander Delivery System
Generic name
Pulmonary valve prosthesis percutaneously delivered
Applicant
Edwards Lifesciences, LLC
Date received
2022-08-09
Decision date
2023-03-09
Days to decision
212 days
Decision code
APPR
Product code
NPV
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for the following manufacturing sites to conduct ethylene oxide sterilization of the Commander Delivery System (Models 9600LDS23, 9750CM23, 9600LDS26, and 9750CM26): (1) Sterigenics, Belgium, located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE, and (2) STERIS Tullamore, located at IDA Business and Technology Park, Tullamore Offaly, IE R35 X865

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510(k) clearances by this applicant

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