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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 BFT/BJF/STELIX BR/STELIX II BRF
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP020030
Supplement NumberS009
Date Received01/27/2012
Decision Date02/16/2012
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT.
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