SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)

FDA premarket approval P910023/S098 · decided 2006-04-05

Approval details

PMA number

P910023

Supplement

S098

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-02-02

Decision date

2006-04-05

Days to decision

62 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE HIGH VOLTAGE CAPACITOR, BATTERY, FEEDTHRUS/HEADERS AND DISCRETE COMPONENTS. SPECIFICALLY, ALTERATION OF THE BATTERY PIN CONFIGURATION, MODIFICATION OF THE FEEDTHRU WIRE TUBING LENGTHS AND OF THE METHOD USED FOR APPLYING INSULATION, CHANGE IN THE VALUE OF C36 CAPACITOR FROM 10NF TO 680PF, QUALIFICATION OF AN ALTERNATE ACCELEROMETER SUBSTRATE WITH INTEGRATED RESISTOR CAPACITOR, AND THE SHIFTING OF THE ANCHOR BRIDGE TO FEEDTHRU FLANGE FROM 0.17"

510(k) clearances by this applicant