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Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

FDA premarket approval P200015/S033 · decided 2023-02-22

Approval details

PMA number
P200015
Supplement
S033
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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
2023-01-23
Decision date
2023-02-22
Days to decision
30 days
Decision code
APPR
Product code
NPV
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for various revisions to the Instructions for Use for the SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent to provide additional instruction on deployment of the prestent and extend the recapture limit from 50% to 65%.

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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