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. |
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Device | FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S108 |
Date Received | 12/05/2012 |
Decision Date | 03/20/2014 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100. |
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