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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.
 
DeviceAstra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS499
Date Received05/10/2017
Decision Date06/04/2017
Product Code NVZ 
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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