|
Device | OPTISENSE MODEL 1999 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 | S057 |
Date Received | 03/12/2010 |
Decision Date | 11/26/2010 |
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 A DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD. |
Approval Order | Approval Order |