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 | ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S024 |
Date Received | 10/16/2006 |
Decision Date | 01/09/2008 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ISOLINE 2CT DEFIBRILLATION LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOLINE 2CT5 & 2CT6 TRANSVENOUS DEFIBRILLATION LEADS AND IS INDICATED TO PROVIDE RIGHT VENTRICULAR PACING, SENSING AND DEFIBRILLATION WHEN USED AS PART OF AN ELA MEDICAL IMPLANTABLE DEFIBRILLATOR. |
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