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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 NameSWEET TIP RX/ FLEXTEND LEAD FAMILY
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous bipolar pacing lead
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960006
Supplement NumberS039
Date Received05/22/2013
Decision Date08/07/2013
Product Code
NVY[ Registered Establishments with NVY ]
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 lead stabilizer kit 6503 and lead cap kit 6504, which are accessory kits intended to be used with the boston scientific corporation (bsc) lead products approved in the devices.
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