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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC CARDIAC SURGERY
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576
PMA NumberP790018
Supplement NumberS043
Date Received03/22/2002
Decision Date04/09/2002
Withdrawal Date 12/23/2011
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT MEDTRONIC, SPRING LAKE PARK, MINNESOTA. MANUFACTURING OPERATIONS RELATED TO FABRICATION OF THE SEWING RING, ATTACHMENT OF THE CONDUIT AND SEWING RING TO THE DISC AND HOUSING SUBASSEMBLY, AND STERILE AND FINAL PACKAGING PROCESSES FOR THE MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT PROSTHESIS (MODEL R7700) WILL BE PERFORMED AT THIS FACILITY.
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