Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HALL (TM) EASY-FIT PROSTHETIC HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC CARDIAC SURGERY 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432-3576 |
PMA Number | P790018 |
Supplement Number | S037 |
Date Received | 04/19/2001 |
Decision Date | 11/09/2001 |
Withdrawal Date
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12/23/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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