PMA P970031S077

Device: Freestyle Bioprosthesis, Models 995, 995CS, 995MS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S077
Product code: LWR
Decision date: 2025-10-23
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly

Current openFDA PMA Record#

Device: Freestyle Bioprosthesis, Models 995, 995CS, 995MS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S077
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-10-23
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly