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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.
 
DeviceMEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
MEDTRONIC 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
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
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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