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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 NameFLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/RETRACTABLE PACING LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous bipolar pacing lead
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960006
Supplement NumberS034
Date Received06/19/2012
Decision Date07/12/2012
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional supplier for a lead tip component.
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