|
Device | MEDTRONIC ATTAIN STARFIX MODEL 4195 LEADS |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P060039 |
Supplement Number | S056 |
Date Received | 02/07/2014 |
Decision Date | 08/04/2014 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00893386
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS. |