CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA

FDA premarket approval P890003/S262 · decided 2013-02-08

Approval details

PMA number

P890003

Supplement

S262

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A, AND MODEL 2491 DDMA

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2012-09-26

Decision date

2013-02-08

Days to decision

135 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE.

510(k) clearances by this applicant