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 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S021 |
Date Received | 05/16/2005 |
Decision Date | 01/15/2008 |
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: 1) MODIFICATIONS TO THE SWIFT 1CT SERIES ICD LEAD TO CREATE A DUAL-COIL, INTEGRATED BIPOLAR, ACTIVE-FIXATION ICD LEAD. THE NEW LEAD WILL BE MARKETED UNDER THE NAME ISOLINE 2CR AND IS INDICATED FOR USE WITH ELA MEDICAL IMPLANTABLE DEFIBRILLATORS; 2) MANUFACTURING SITE AT SORIN BIOMEDICA CRM SRL, SALUGGIA, ITALY AND TWO STERILIZATION SITES AT BIOSTER SPA, BERGAMO, ITALY. |
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