PMA P040021S059

Device: Epic™ Plus Stented Tissue Valve; Epic™ Max Stented Tissue Valve
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S059
Product code: LWR
Decision date: 2025-07-29
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: two changes to the EO sterilization of components, processing aids, and Jar Set Assemblies (JSAs) - an addition of a duplicate sterilization chamber at an existing sterilization site, and the addition of an alternate sterilization facility

Current openFDA PMA Record#

Device: Epic™ Plus Stented Tissue Valve; Epic™ Max Stented Tissue Valve
Applicant: ABBOTT MEDICAL
PMA number: P040021
Supplement: S059
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-07-29
Decision code: OK30
Date received: 2025-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: two changes to the EO sterilization of components, processing aids, and Jar Set Assemblies (JSAs) - an addition of a duplicate sterilization chamber at an existing sterilization site, and the addition of an alternate sterilization facility