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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.
 
DeviceCAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED 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 NumberS039
Date Received04/20/1998
Decision Date08/12/1998
Product Code DTB 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.
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