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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.
 
DevicePASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS
Generic NamePermanent defibrillator electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS031
Date Received05/20/2010
Decision Date08/13/2015
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
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