ADVISA MRI

FDA premarket approval P980035/S308 · decided 2013-03-07

Approval details

PMA number

P980035

Supplement

S308

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ADVISA MRI

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2013-02-07

Decision date

2013-03-07

Days to decision

28 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VA

510(k) clearances by this applicant