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Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve

FDA premarket approval P150048/S060 · decided 2022-12-29

Approval details

PMA number
P150048
Supplement
S060
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
Generic name
heart-valve, non-allograft tissue
Applicant
Edwards Lifesciences, LLC
Date received
2022-02-04
Decision date
2022-12-29
Days to decision
328 days
Decision code
APPR
Product code
LWR
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for a manufacturing site located at 35 Changi North Crescent, Changi, Singapore, 499641 for RESILIA/GLX processing and final packaging of the INSPIRIS RESILIA Aortic Valves, as well as an alternate ethylene oxide sterilization site at Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491.

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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