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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.
 
Device8085 PREVAIL IMPLANTABLE PULSE GENERATOR
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850051
Supplement NumberS055
Date Received06/30/2000
Decision Date07/21/2000
Product Code LWO 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115 AND VITATRON VISA SR MODEL 415.
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