Atlas FDA

Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses

FDA premarket approval P860057/S202 · decided 2021-12-13

Approval details

PMA number
P860057
Supplement
S202
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprostheses
Generic name
replacement Heart-valve
Applicant
Edwards Lifesciences, LLC
Date received
2021-07-20
Decision date
2021-12-13
Days to decision
146 days
Decision code
APPR
Product code
DYE
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for the manufacturing of the Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis (MAGNA Model 3300TFX) at the Edwards Cartago, Costa Rica Facility, limited to cleaning and sterilization of components, bioburden reduction, final assembly, terminal liquid sterilization, and packaging and labeling prior to commercial release.

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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