|
Device | TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S010 |
Date Received | 03/06/2002 |
Decision Date | 03/27/2002 |
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 THE LOCATOR STEERABLE STYLET MODEL 4036 FOR USE WITH TENDRIL DX MODEL 1388 T/TC/K AND TENDRIL SDX MODEL 1488 T/TC/K ENDOCARDIAL PACING LEADS. |