|
Device | EPIC HF/ATLAS+HF FAMILY OF CRT-DS |
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 | S126 |
Date Received | 05/21/2009 |
Decision Date | 06/18/2009 |
Product Code |
NIK
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
MODIFICATION OF THE PLACEMENT PROCESS OF THE TELEMETRY COIL SUBSTRATE ONTO THE NYLON SUPPORT ASSEMBLY. |