|
Device | MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 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 | S024 |
Date Received | 10/01/2001 |
Decision Date | 11/02/2001 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MEDTRONIC SPRINT QUATTRO SECURE MODEL 6947 LEAD. THE DEVICE IS INDICATED FOR SINGLE LONG-TERM USE IN THE RIGHT VENTRICLE. THIS LEAD HAS APPLICATION FOR PATIENTS IN WHICH ARRHYTHMIA MANAGEMENT SYSTEMS ARE INDICATED. |