|
Device | ATLAS II + HF CRT-D SYSTEM |
Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Generic Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
Applicant |
St. Jude Medical |
15900 valley view ct. |
sylmar, CA 91342-3577 |
|
PMA Number | P030054 |
Supplement Number | S067 |
Date Received | 09/05/2007 |
Decision Date | 01/13/2009 |
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
|
Approval Order Statement
APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 7020Q, 7021Q, 7022Q, AND RIATA STS OPTIM 7120Q, 7121Q, 7122Q; AND PROGRAMMER MODELS SJM 3510 AND MERLIN 3650. |
Post-Approval Study | Show Report Schedule and Study Progress |