|
Device | TENDRIL SDX MODEL 1488T/TC/K |
Generic Name | permanent pacemaker Electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S011 |
Date Received | 11/22/2002 |
Decision Date | 02/25/2003 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TENDRIL LEAD LENGTH CHANGE. |