INDENTITY & IDENTITY ADX FAMILY OF DEVICES

FDA premarket approval P880086/S150 · decided 2007-07-12

Approval details

PMA number

P880086

Supplement

S150

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2007-06-20

Decision date

2007-07-12

Days to decision

22 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

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.

510(k) clearances by this applicant