|
Device | TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K |
Generic Name | permanent pacemaker Electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S012 |
Date Received | 12/04/2002 |
Decision Date | 01/22/2003 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS. |