|
Device | TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S016 |
Date Received | 02/06/2006 |
Decision Date | 03/02/2006 |
Product Codes |
DTB NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION. |