HALL (TM) EASY-FIT PROSTHETIC HEART VALVE
FDA premarket approval P790018/S037 · decided 2001-11-09
Approval details
- PMA number
- P790018
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HALL (TM) EASY-FIT PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2001-04-19
- Decision date
- 2001-11-09
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- 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 SUPR
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