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Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V

FDA premarket approval P150048/S044 · decided 2020-03-05

Approval details

PMA number
P150048
Supplement
S044
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V
Generic name
heart-valve, non-allograft tissue
Applicant
Edwards Lifesciences, LLC
Date received
2020-02-07
Decision date
2020-03-05
Days to decision
27 days
Decision code
OK30
Product code
LWR
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.

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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