|
Device | LEAD ADAPTOR/SPRINT QUATTRO/ SPRINT QUATTRO LEAD/SUBCUTANEOUS LEAD/TRANSVENE SVC 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 | S084 |
Date Received | 11/21/2011 |
Decision Date | 02/28/2013 |
Product Code |
LWS |
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 MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE SPRINT QUATTRO DEFIBRILLATION LEAD ADAPTORS, SPRINT QUATTRO DEFIBRILLATION LEADS; TRANSVENE SVC DEFIBRILLATION LEAD, AND SUBCUTANEOUS DEFIBRILLATION LEAD. |