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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 CAPSURE(R) SP MODEL 5024M/5524M PACING LEADS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850089
Supplement NumberS035
Date Received05/08/1996
Decision Date03/07/1997
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF NUSIL MED-4719 AS AN ALTERNATE SILICONE INSULATOR FOR MDX4-4516
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