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 | DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S139 |
Date Received | 08/04/2014 |
Decision Date | 02/10/2015 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INVENTRA, IPERIA AND ITREVIA ICD AND CRT-D DEVICES AS WELL AS UPDATES TO NON-IMPLANTED COMPONENTS RENAMIC, PSW 1401.U AND THE HOME MONITORING SERVICE CENTER TO SUPPORT THE INTRODUCTION OF THE NEW ICD AND CRT-D DEVICES. |
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