|
Device | OPTISENSE RIGHT ATRIAL LEAD |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S038 |
Date Received | 05/01/2008 |
Decision Date | 10/01/2009 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE OPTISENSE MODEL 1999 RIGHT ATRIAL LEAD. |