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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, RELIA, SENSIA, & VERSA
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS233
Date Received06/29/2011
Decision Date07/28/2011
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  
FIVE CHANGES TO GEN2 HYBRID TESTER FINAL TEST SOLUTION: 1) UPDATE TO THE FORCE MEASURE_NGT2 MODULE; 2) UPDATE THE PULSE AMPLITUDE AND PULSE WIDTH TEST , PULSE AMPLITUDE 7500 MV AND AMPLITUDE 7500 MV TEST SEQUENCES; 3) WIDEN THE TOLERANCE OF THE STABILITY CHECK CRITERIA FOR THE PULSE AMPLITUDE AND PULSE WIDTH TEST ;4) UPDATE THE CONFIGURATION SETTINGS FOR THE PULSE AMPLITUDE 7500 MV AND UNIPOLAR BIPOLAR SWITCH TEST AND THE INTER-CHAMBER CROSSTALK TEST; AND 5) UPDATE THE ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) CYCLIC REDUNDANCY CHECK (CRC).
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