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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 STEROID COLLAR
Generic NamePermanent defibrillator electrodes
ApplicantMicroPort CRM S.r.l.
Via Crescentino S.N.
Saluggia 13040
PMA NumberP020030
Supplement NumberS007
Date Received08/23/2010
Decision Date03/15/2012
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR IMPROVING THE STEROID COLLAR MANUFACTURING PROCESS.
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