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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSWEET TIP RX,SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEMS
Generic NamePermanent defibrillator electrodes
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960006
Supplement NumberS040
Date Received08/29/2013
Decision Date09/25/2013
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
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