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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 PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
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 NumberS044
Date Received08/29/2003
Decision Date09/23/2003
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ELIMINATION OF THE PRODUCTION PULSE DUPLICATION TEST FROM THE MANUFACTURING PROCESS.
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