PMA approvals

Edwards EVOQUE Tricuspid Valve Replacement System

Edwards Lifesciences, LLC · Percutaneously Delivered Prostheses and Tricuspid Valves · Cardiovascular

P230013 S029SupplementApproved
Open FDA's page for this record
PMA number
P230013
Supplement number
S029
Applicant
Edwards Lifesciences, LLC
Street 1
One Edwards Way
City
Irvine
State
CA
Zip
92614
Generic name
Percutaneously Delivered Prostheses and Tricuspid Valves
Trade name
Edwards EVOQUE Tricuspid Valve Replacement System
Product code
NPW
Advisory committee
CV
Advisory committee description
Cardiovascular
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-04-28
Decision date
2026-10-19
Decision code
APPR
Ao statement
Approval for updated specifications for the Coated Capsule to allow signs of delamination on the inner diameter of the proximal weld ring.
Harmonized identifiers (openFDA)
Device name
Percutaneously Delivered Prostheses And Tricuspid Valves
Medical specialty description
Unknown
Device class
3
Registration number
3008500478, 1721676, 2011171, 3007063218, 2015691
FEI number
1721676, 2011171, 3007063218, 2015691, 1713910
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.