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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 NameATTAIN LV,CS, BIPOLAR OTW
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC VASCULAR
PMA NumberP010015
Supplement NumberS028
Date Received05/18/2007
Decision Date06/15/2007
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the molding vendor for the ring to pin component.
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