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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.
 
DevicePercepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P,
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS327
Date Received05/10/2017
Decision Date06/04/2017
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1) New supplier for material used in battery manufacturing; implementation of an update to FACTORYworks (FW) Release 9.3.; 2) updated test equipment for use in battery manufacturing; 3) changes to the acceptance parameter specification limits for certain wafers and associated process changes; 4) the addition of mixing equipment used in battery manufacturing; 5) an additional laser welder for use in battery manufacturing; and 6) changes to the manufacturing process flow at an integrated circuit component supplier as well as the addition of visual inspection requirements.
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