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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 MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pacemaker pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS009
Date Received03/05/2003
Decision Date03/27/2003
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medtronic b. V. , european operations center, heerlen, the netherlands. Final device packaging will be performed at this facility.
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