|
Device | TENDRIL STS 1988TC AND 2088TC |
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 | S066 |
Date Received | 07/22/2011 |
Decision Date | 11/01/2011 |
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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THREE ADDITIONAL LEAD LENGTHS OF 65, 85 AND 100 CM IN THE TENDRIL STS PACEMAKER LEADS. |
Approval Order | Approval Order |