|
Device | ST. JUDE MEDICAL EPIC HF SYSTEM |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030054 |
Supplement Number | S155 |
Date Received | 06/22/2010 |
Decision Date | 02/11/2011 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW 4.3-4.7 FR SLIT SUTURE SLEEVE ACCESSORY KIT TO BE USED WITH THE APPROVED 1258T QUICKFLEX ¿ LEAD. |