|
Device | SPRINT QUATTRO SINGLE COIL DF4, ACTIVE FIXATION LEAD |
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 | S091 |
Date Received | 05/23/2012 |
Decision Date | 07/02/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE TO THE CURRENTLY APPROVED MODEL 6935 SPRINTQUATTRO SECURE S LEAD WHICH IS A SINGLE DEFIBRILLATION COIL IS-1/DF-1 ACTIVE FIXATION LEAD FOR THE CREATION OF A NEW SPRINT QUATTRO SECURE S SINGLE DEFIBRILLATION COIL DF4 ACTIVE FIXATION LEAD, MODEL 6935M. |