|
Device | ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 |
Classification Name | implantable pulse generator, pacemaker (non-crt) |
Generic Name | implantable pulse generator, pacemaker (non-crt) |
Applicant |
Boston Scientific Corp. |
4100 hamline ave north |
st. paul, MN 55112 |
|
PMA Number | P010012 |
Supplement Number | S160 |
Date Received | 10/09/2007 |
Decision Date | 05/16/2008 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 180 day track |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR. |
Post-Approval Study | Show Report Schedule and Study Progress |