PMA P790018S037

Device: HALL (TM) EASY-FIT PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S037
Product code: LWQ
Decision date: 2001-11-09
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR THE HALL EASY-FIT PROSTHETIC HEART VALVE, MODELS A7700 (AORTIC) AND M7700 (MITRAL), AVAILABLE IN AORTIC SIZES 19, 21, 23, 25, 27, AND 29 MM, AND IN MITRAL SIZES 23, 25, 27, 29, AND 31 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES. THE HALL PROSTHETIC HEART VALVE IS A MODIFICATION OF THE APPROVED MEDTRONIC HAL PROSTHETIC HEART VALVE; THE MODIFICATION CONSISTING OF A NEW SEWING CUFF MATERIAL AND DESIGN, INTENDED FOR SUPRA-ANNULAR PLACEMENT. THE SUPPLEMENT ADDITIONALLY REQUESTED INTRODUCTION OF THE HALL E PROSTHETIC HEART VALVE PRODUCT LINE INTO THE APPROVED STEAM STERILIZATION PROCESS FOR THE MEDTRONIC H PROSTHETIC HEART VALVE.

Current openFDA PMA Record#

Device: HALL (TM) EASY-FIT PROSTHETIC HEART VALVE
Applicant: Medtronic Cardiac Surgery
PMA number: P790018
Supplement: S037
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2001-11-09
Decision code: APPR
Date received: 2001-04-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE HALL EASY-FIT PROSTHETIC HEART VALVE, MODELS A7700 (AORTIC) AND M7700 (MITRAL), AVAILABLE IN AORTIC SIZES 19, 21, 23, 25, 27, AND 29 MM, AND IN MITRAL SIZES 23, 25, 27, 29, AND 31 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES. THE HALL PROSTHETIC HEART VALVE IS A MODIFICATION OF THE APPROVED MEDTRONIC HAL PROSTHETIC HEART VALVE; THE MODIFICATION CONSISTING OF A NEW SEWING CUFF MATERIAL AND DESIGN, INTENDED FOR SUPRA-ANNULAR PLACEMENT. THE SUPPLEMENT ADDITIONALLY REQUESTED INTRODUCTION OF THE HALL E PROSTHETIC HEART VALVE PRODUCT LINE INTO THE APPROVED STEAM STERILIZATION PROCESS FOR THE MEDTRONIC H PROSTHETIC HEART VALVE.