PMA P130011S001

Device: SOLO SMART STENTLESS HEART VALVE
Applicant: Corcym Canada Corp
PMA number: P130011
Supplement: S001
Product code: LWR
Decision date: 2015-07-22
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.

Current openFDA PMA Record#

Device: SOLO SMART STENTLESS HEART VALVE
Applicant: Corcym Canada Corp
PMA number: P130011
Supplement: S001
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2015-07-22
Decision code: OK30
Date received: 2015-06-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.