|
Device | MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S022 |
Date Received | 05/31/2001 |
Decision Date | 06/15/2001 |
Product Code |
LWS |
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 MODEL 6726 DF-1 Y-ADAPTOR/EXTENDER KIT. THE DEVICE IS INDICATED TO ADAPT TWO DF-1 LEAD CONNECTORS TO A SINGLE DF-1 COMPATIBLE CONNECTOR PORT AND/OR WILL EXTEND THE LENGTH OF A DF-1 LEAD CONNECTOR. THE MODEL 6726 HAS APPLICATION FOR PATIENTS IN WHICH IDC SYSTEMS ARE INDICATED. |