|
Device | SPRINT QUATTRO LEADS MODELS 6935/6947 |
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 | S069 |
Date Received | 10/22/2010 |
Decision Date | 11/10/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR LABELING CHANGES WARNING PHYSICIANS ABOUT OVER-RETRACTION OF THE HELIX IN THE SUBJECT LEADS. |