|
Device | SPRINT QUATTRO STEROID-ELUTING LEAD MODEL 6944 |
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 | S028 |
Date Received | 04/28/2003 |
Decision Date | 07/21/2003 |
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 ADDITION OF THE DEXAMETHASONE SODIUM PHOSPHATE (DSP) STEROID TO THE LEAD TIP. |