|
Device | LEAD TUNNELER MODEL 6888 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830060 |
Supplement Number | S062 |
Date Received | 02/24/2009 |
Decision Date | 11/10/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |