PMA P170006S038

Device: Avalus Bioprosthesis, Avalus Ultra Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P170006
Supplement: S038
Product code: LWR
Decision date: 2025-11-10
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for implementation of updates to the product labels and IFUs, and the implementation of a new temperature indicator on the secondary package shelf cartons for the Mosaic, Hancock II, Avalus, and Freestyle bioprostheses

Current openFDA PMA Record#

Device: Avalus Bioprosthesis, Avalus Ultra Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P170006
Supplement: S038
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-11-10
Decision code: APPR
Date received: 2025-08-13
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for implementation of updates to the product labels and IFUs, and the implementation of a new temperature indicator on the secondary package shelf cartons for the Mosaic, Hancock II, Avalus, and Freestyle bioprostheses