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Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

FDA premarket approval P200015/S011 · decided 2021-12-16

Approval details

PMA number
P200015
Supplement
S011
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Generic name
Pulmonary valve prosthesis percutaneously delivered
Applicant
Edwards Lifesciences, LLC
Date received
2021-06-21
Decision date
2021-12-16
Days to decision
178 days
Decision code
APPR
Product code
NPV
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent. The device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.

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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