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 LEAD MODELS |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S060 |
Date Received | 05/14/2009 |
Decision Date | 07/10/2009 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR PASSIVE FIXATION DURATA LEADS WITH SJ4 FOUR-POLE PROXIMAL CONNECTORS; MODEL NUMBERS 7170Q AND 7171Q. |
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