| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| 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 |