CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER

FDA premarket approval P890003/S260 · decided 2013-09-05

Approval details

PMA number

P890003

Supplement

S260

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2012-09-13

Decision date

2013-09-05

Days to decision

357 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR MULTIPLE DESIGN CHANGES, PACKAGING CHANGES, LABELING CHANGES, MANUFACTURING PROCESS CHANGES, AND A MANUFACTURING FACILITY TRANSFER TO TECHNICAL SERVICES FOR ELECTRONICS, INC., TSE TAIWAN MANUFACTURING FACILITY, WITH PACKAGING ACTIVITIES TO OCCUR AT THE TSE FACILITY IN JACKSON, MINNESOTA FOR THE 2090 EC/ECL ECG CABLE AND LEAD WIRES AND 148743 ECG PLUG.

510(k) clearances by this applicant