Heart-Valve, Mechanical
Basic Information
- Device Name
- Heart-Valve, Mechanical
- Trade Name
- HALL (TM) EASY-FIT PROSTHETIC HEART VALVE
- PMA Number
- P790018
- Supplement Number
- S037
- Device Class
- FDA Class 3
- Product Code
- LWQ
- Generic Name
- HEART-VALVE, MECHANICAL
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 9, 2001
- Date Received
- April 19, 2001
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | FDA class 3 | Unknown |