|
Device | 1258T AND 1458Q FAMILY OF LEADS |
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 | S246 |
Date Received | 06/03/2013 |
Decision Date | 11/14/2013 |
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 MODIFICATION TO THE WELD SHAFT COMPONENT ON 1258T AND 1458Q LEAD FAMILIES. |