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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 AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
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 NumberS041
Date Received11/19/2001
Decision Date04/23/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS. THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).
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