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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.
 
DeviceADAPTA/VERSA/SENSIA IPG
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS303
Date Received01/14/2013
Decision Date02/07/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
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