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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantMEDTRONIC VASCULAR
PMA NumberP790018
Supplement NumberS043
Date Received03/22/2002
Decision Date04/09/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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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