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 | DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S083 |
Date Received | 09/05/2012 |
Decision Date | 10/16/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PACKAGING OF THE QUARTET IS4 AND DURATA DF4 LEADS. |
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