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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.
 
DeviceSTELID II BTF/BJF - STELIX II BRF
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP020030
Supplement NumberS010
Date Received09/11/2013
Decision Date10/02/2013
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE ROUTINE BIOBURDEN MONITORING BEFORE STERILIZATION.
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