|
Device | ATTAIN STARFIX LEAD |
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 | S006 |
Date Received | 08/27/2009 |
Decision Date | 02/02/2010 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR SHELF LIFE EXTENSION FROM 18 TO 24 MONTHS FOR THE ATTAIN STARFIX LEAD MODEL 4195. |