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 | MEDTRONIC-HALL 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 | S027 |
Date Received | 03/05/1996 |
Decision Date | 08/19/1996 |
Withdrawal Date
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12/23/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TRANSFER OF SEWING RING FABRICATION AND ATTACHMENT, AND STERILE PACKAGING MANUFACTURING PROCESSES FROM YOUR FACILITY LOCATED AT 7000 CENTRAL AVE., MINNEAPOLIS, MN TO YOUR FACILITY AT 18011 S.MITCHELL, IRVINE, CA |
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