|
Device | INDENTITY & IDENTITY ADX FAMILY OF DEVICES |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S150 |
Date Received | 06/20/2007 |
Decision Date | 07/12/2007 |
Product Code |
NVZ |
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 USE OF THE CIRCUITRY USE DIN THE ANALOG CHIP IN THE VICTORY/ZEPHYR FAMILY OF DEVICES IN THE ANALOG CHIP USED IN THE IDENTITY AND IDENTITY ADX FAMILY OF DEVICES, AND FOR RESIZING THE SENSE AND IEGM GAIN CAPACITORS. |