|
Device | OPTISURE |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S085 |
Date Received | 10/24/2012 |
Decision Date | 02/21/2014 |
Product Code |
NVY |
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 OPTISURE HIGH VOLTAGE LEAD FAMILY. |
Post-Approval Study | Show Report Schedule and Study Progress |