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EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System

FDA premarket approval P230013/S001 · decided 2024-03-15

Approval details

PMA number
P230013
Supplement
S001
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System
Generic name
Percutaneously Delivered Prostheses and Tricuspid Valves
Applicant
Edwards Lifesciences, LLC
Date received
2024-02-26
Decision date
2024-03-15
Days to decision
18 days
Decision code
APPR
Product code
NPW
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for a manufacturing site located at 12050 Lone Peak Parkway, Draper, UT 84020 as an alternative finished goods manufacturing site for the EVOQUE transcatheter tricuspid delivery system, EVOQUE dilator kit, and EVOQUE loading System

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510(k) clearances by this applicant

RecordFirmDate
Respiration Rate algorithm (K251326)Edwards Lifesciences, LLC2026-06-11
HemoSphere Nano Monitor (HSNANO1) (K253186)Edwards Lifesciences, LLC2026-02-24
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
Hypertension Prediction Index (HePI) Algorithm (K242518)Edwards Lifesciences, LLC2025-05-15
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909)Edwards Lifesciences, LLC2025-03-21
Fogarty Thru-Lumen Embolectomy Catheter (K240078)Edwards Lifesciences, LLC2024-08-28
Acumen Assisted Fluid Management (AFM) Software Feature (K233984)Edwards Lifesciences, LLC2024-08-02