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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,RELIA IPG
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS348
Date Received09/26/2013
Decision Date10/25/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
SUPPLIER SITE LOCATION TRANSFER AND PROCESS CHANGES FOR AN ACCELEROMETER CRYSTAL USED IN MODELS ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01, SED01, SEDR01, SEDRL1, SES01, SESR01, AND VEDR01 AND RELIA IPG MODELS RED01, REDR01, RES01, RESR01, AND REVDD01.
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