PMA P970031

Device: Freestyle Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S069
Product code: LWR
Decision date: 2026-02-12
Generic name: heart-valve, non-allograft tissue
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: Freestyle Bioprosthesis
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S078
Product code: LWR
Generic name: heart-valve, non-allograft tissue
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