|
Device | SPRINT QUATTRO LEADS |
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 | S099 |
Date Received | 10/31/2012 |
Decision Date | 12/19/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MECHANICAL DESIGN CHANGE TO THE SPRINT QUATTRO MODEL 6935M AND MODEL 6947M LEAD ANALYZER CABLE INTERFACE ACCESSORY. |