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Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi

FDA premarket approval P150048/S065 · decided 2022-09-08

Approval details

PMA number
P150048
Supplement
S065
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
Generic name
heart-valve, non-allograft tissue
Applicant
Edwards Lifesciences, LLC
Date received
2022-06-03
Decision date
2022-09-08
Days to decision
97 days
Decision code
APPR
Product code
LWR
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for a manufacturing site located at Edwards Costa Rica Cartago (Zona Franca La Lima, De La Entrada De Pequeno Mundo 100 Mts Oeste Y 200 Mts Sur Finca 31 Y 32 Guadalupe Cartago 30106 CR) for subassembly of bioprosthetic heart valves.

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510(k) clearances by this applicant

RecordFirmDate
Respiration Rate algorithm (K251326)Edwards Lifesciences, LLC2026-06-11
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Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
Hypertension Prediction Index (HePI) Algorithm (K242518)Edwards Lifesciences, LLC2025-05-15
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