|
Device | LEAD TUNNELER MODEL 6888 |
Classification Name | implantable cardioverter defibrillator (non-crt) |
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 | |
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 |