PMA P980043S084

Device: Hancock II Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P980043
Supplement: S084
Product code: DYE
Decision date: 2025-11-10
Classification: Cardiovascular
Generic name: replacement Heart-valve
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: Hancock II Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P980043
Supplement: S084
Product code: DYE
Generic name: replacement Heart-valve
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