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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.
 
DevicePASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS005
Date Received04/01/1999
Decision Date08/26/1999
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Model 1336T Passive Plus(R) DX Endocardial, Steroid Eluting, Passive Fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.
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