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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINSYNC III
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS031
Date Received07/26/2007
Decision Date09/18/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the xm485 and xm486 wire bond terminal blocks found in medtronic kappa 700, kappa 900, enpulse, adapta/versa/ sensia, sigma, 350 series, thera/prodigy, kappa 400, and insync-ii implantable pulse generator and cardiac resynchronization therapy pacemaker (crt-p) families.
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