|
Device | TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S001 |
Date Received | 09/24/1997 |
Decision Date | 03/19/1998 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of Thermedics Tecothane T11075D-M for molded polyurethane components as a replacement for Pellethane 2363-75D. FDA also acknowledges your marketing of the Tenril DX Model 1388T/C lead, which is identical to the approved Model 1388t lead, except that it is packaged only with the clip-on tool accessory. |