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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.
 
DeviceMEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St.
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980050
Supplement NumberS145
Date Received02/13/2025
Decision Date03/20/2025
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
approval for a predetermined change control plan (PCCP) that encompasses the following biocompatibility-related manufacturing changes, provided that they do not impact the properties of the device materials, for the devices under the above PMAs:1. Removal of a processing aid (solvent, lubricant, antifoaming agent, etc.), or cleaning agent2. Removal of a cleaning process3. Change in parameters (temperature, time, sonication, etc.) of a current cleaning process
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