PMA P980043

Device: Hancock II Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P980043
Supplement: S075
Product code: DYE
Decision date: 2026-02-12
Generic name: replacement Heart-valve
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs

Current openFDA PMA Record#

Device: Hancock II Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P980043
Supplement: S086
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2026-02-12
Decision code: APPR
Date received: 2025-09-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a Pre-Determined Change Control Plan (PCCP) that establishes a standardized qualification process for new bovine and porcine tissue suppliers, provided they do not impact the tissue's specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMAs