|
Device | QUICKFLEX U MODEL 1258T LEAD |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S130 |
Date Received | 07/16/2009 |
Decision Date | 05/10/2010 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00763698
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE QUICKFLEX µ MODEL 1258TLEFT VENTRICULAR LEAD. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |