|
Device | SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935 |
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 | S039 |
Date Received | 03/03/2008 |
Decision Date | 04/29/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A SINGLE-DEFIBRILLATION-COIL VERSION OF THE FDA APPROVED SPRINT QUATTRO MODEL 6947 DUAL-DEFIBRILLATION ?COIL ACTIVE-FIXATION RIGHT VENTRICULAR LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER TE TRADE NAME SPRINT QUATTRO MODEL 6935 LEAD AND IS INTENDED FOR LONG-TERM USE IN THE RIGHT VENTRICLE FOR PATIENTS INDICATED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. |