|
Device | ST JUDES MEDICAL ICDS AND CRT-DS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S014 |
Date Received | 10/11/2005 |
Decision Date | 11/28/2005 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE SEPTUM DESIGN OF ALL ST. JUDE MEDICAL ICDS AND CRT-DS. |
Post-Approval Study | Show Report Schedule and Study Progress |